Using AI based chatbots to seek answers to regulatory questions

mobile phone with chatbot image

Since the end of November 2022 when Open.ai introduced ChatGPT to the world, there has been an explosion of chatbots which include the following:

  • Bard (Google) – Provides three draft answers to each question
  • Microsoft Copilot with Bing Chat (Microsoft) (search engine)-
  • Claude.ai (Anthropic)
  • Perplexity.ai (search engine) – Has a ‘Copilot’ version for a subscription which asks you questions in order to refine your question in order to provide a response.
  • Zephyr 7B Beta (Hugging Face) – You can learn more about it here

Some of these are chatbots e.g. ChatGPT and others are search engines e.g. Perplexity.ai or Microsoft Copilot with Bing Chat.

  • Each chatbot has a free version available (albeit often with some limitations)
  • Some chatbots have paid versions e.g. ChatGPT Plus, Perplexity Pro and Claude Pro. Essentially, these Pro versions provide access to the latest version of GPT i.e. GPT 4 as well as other features. Note that you can also access GPT 4 via Microsoft Copilot with Bing without a subscription.
  • There are also apps for ChatGPT (AppStore; Google Play) Bing and Perplexity.ai (AppStore; Google Play)
Why it is important to try out more than one chatbot?

It seems that whenever one mentions chatbots, people immediately think of ChatGPT. No matter how much you like ChatGPT, please do try out at least one or more of the others listed above. Each has its own merits. You may be pleasantly surprised and might even even consider using it side by side with ChatGPT or switching away from ChatGPT altogether.

If you haven’t test driven any of them yet. please do so. Ignore them at your peril as they are here to stay and will only get much better over time with each iteration. They will quite likely have a significant impact on work life over the coming years (and they appear to be doing that already to some extent in some professions).

Try using a chatbot to research a regulatory topic that you know little or nothing about

For the purposes of this post, I have used one example as explained below.

Imagine that you have little or no idea about the routes for licensing medicines available in the US. You have been asked to do a search in order to find out some basic information about the available routes.

I asked the question below to all the above named chatbots.

What are the various routes for licensing medicines in the US? Provide a synopsis of each route, including accelerated approval routes.

The responses to the question asked are tabulated at the end of this post.

About the responses to the question asked

As expected, the response to the same question (from each chatbot) are not identical. Some points worthy of note concerning the responses are:

  • Only the responses from Microsoft Copilot with Bing Chat And Perplexity.ai include references.
    • The response from Perplexity.ai lists six references but only three are referenced in the response.
  • The response from Microsoft Copilot with Bing Chat does not even mention the main routes of licensing e.g. NDA, BLA etc.
  • Only responses from ChatGPT 3.5 and Claude.ai mention Orphan registration as a licensing route
  • The response from Perplexity.ai incorrectly lists Investigational New Drug (IND) as a route route of licensing. Oddly, the response also refers to routes of licensing in the EU even though this was not part of the question.
  • Draft 2 of of the Google Bard response starts out by saying that there are TWO main routes for licensing medicines in the US and Draft 3 starts by saying that there are THREE routes, but then both of the responses go on to give similar information except that Draft 2 mentions the Pediatric Priority Review Voucher (PPV) and Draft 3 mentions the Regenerative Medicine Advanced Therapy (RMAT) program
  • Only the Draft 2 response from Google Bard and the response from Zephyr 7B Beta mention the Paediatric Priority Review Voucher
  • Only Draft 3 of the Google Bard response and the Zephyr 7B beta chat response mention the Regenerative Medicine Advanced Therapy (RMAT) program

You will no doubt come up with other points for consideration when you read the responses closely.

What are some of the things to think about when using chatbots to seek answers to regulatory questions?
  • How you word a question is critical to the response that you get. For example, if the question asked in this case was amended to What are the various routes for licensing medicines in the US? Provide a synopsis of each route? with no mention of the accelerated approval routes, would the responses have mentioned the accelerated routes of licensing? You might want to ask the question to the chatbots and find out for yourself.
  • Try and word a question in several different ways and see if you get the same or similar answers, or much improved answers.
  • It seems not a good idea to rely on one chatbot to provide a complete and correct response. At the very least, you should contemplate the idea of using two or more chatbots and ask the exact same question to each. There is no guarantee that a response will ever be entirely correct and complete from any of the chatbots.
  • Wooly questions are more than likely to elicit wooly responses. Spend some time refining your question(s) in order to increase the chances of getting a sensible response
  • It is not a sound idea to use a response from a chatbot as a definitive answer without verifying the response by referring to multiple sources. Check and check again until you are sure.

Perhaps the most important thing to be aware of is that when the exact same question is asked to each chatbot on different days, the answer can vary substantially. I have already experienced this on many occasions.

Based on the responses to the question asked, it seems that none of the chatbots in their current iteration are able to provide a correct and complete response to the question asked. Note that I used the free version of each chatbot to ask the question. As I do not have a paid subscription for any of the chatbots, I am unable to say whether the paid versions would provide correct or complete responses to the question asked.

It is of course possible that the question asked wsas not refined enough in order to elicit a correct and complete response. You might wish to try asking the same question in different ways and see if the response changes substantially.

Can chatbots be relied upon to answer regulatory questions?

For now at least, it seems that chatbots cannot be relied upon to provide correct and complete responses to regulatory questions. At best, they can be used as a starting point for further research. Whether this will change with future iterations of the chatbots remains to be seen.

Remember though that this is just one of a myriad of uses of chatbots, so you would do well to familiarise yourself with how to use them to your advantange.

If you have any comments concerning this post, please use the the feedback page.

The responses to the question asked

Below are the responses from the chatbots, to the question asked

ChatGPT 3.5Microsoft Copilot with Bing ChatClaude.aiPerplexity.ai
In the United States, the Food and Drug Administration (FDA) is responsible for regulating and approving medicines. There are several routes for licensing medicines, each designed to address different needs and circumstances. Some of these routes, including accelerated approval options, are:
New Drug Application (NDA):
1. The NDA is the most common route for licensing new medicines in the U.S.
· Sponsors (usually pharmaceutical companies) submit extensive data, including preclinical and clinical trial results, chemistry, manufacturing, and labeling information, to the FDA.
· The FDA reviews the application and, if the drug is found to be safe and effective, it is granted approval.
2. Biologics License Application (BLA):
· Similar to the NDA but specifically for biological products, such as vaccines and monoclonal antibodies.
· The BLA includes data on the safety, purity, and potency of the product, as well as clinical trial data.
· The FDA reviews the BLA and grants approval if the product meets safety and efficacy standards.
3. Generic Drug Approval (Abbreviated New Drug Application, ANDA):
· This route is for generic versions of existing, already approved brand-name drugs.
· Generic drug manufacturers submit an ANDA demonstrating that their product is bioequivalent to the reference listed drug (brand-name drug).
· Approval is granted if the generic drug is proven to be equivalent in quality, safety, and efficacy to the reference drug.
4. Over-the-Counter (OTC) Drug Monograph: · OTC drugs are available without a prescription, and their approval is based on established monographs or regulations.
· Manufacturers must comply with specific monographs that detail acceptable ingredients, dosages, labeling, and more.
· No separate application is required if a product conforms to an existing monograph.
5. Orphan Drug Designation:
· This designation is for medicines intended to treat rare diseases or conditions.
· Sponsors receive various incentives, including tax credits, fee waivers, and a period of market exclusivity, to encourage the development of these drugs.
6. Fast Track, Breakthrough Therapy, and Priority Review:
· These are expedited review pathways for drugs targeting serious conditions with unmet medical needs.
· Fast Track designation facilitates close communication with the FDA during development.
· Breakthrough Therapy designation is for drugs showing substantial improvement over existing treatments.
· Priority Review shortens the review timeline.
7. Accelerated Approval:
· This pathway is for drugs that treat serious conditions with an unmet medical need.
· Approval is based on surrogate endpoints (e.g., tumor shrinkage) that are reasonably likely to predict clinical benefit.
· Manufacturers must conduct post-marketing studies to confirm clinical benefit.
8. Expanded Access (Compassionate Use):
· Allows patients with serious or life-threatening conditions to access investigational drugs before they are approved.
· Requests are made to the drug manufacturer, and the FDA may facilitate the process.

These are the main routes for licensing medicines in the U.S., each designed to address different aspects of drug development and approval. The choice of route depends on the nature of the drug, its intended use, and the specific regulatory pathway that best suits the situation.		Licensing medicines in the US is a complex and regulated process that involves different agencies, laws, and procedures. There are several routes for licensing medicines, depending on the type, purpose, and origin of the product. Here are some of the main routes:
FDA Licensing Process: This is the most common route for licensing medicines that are developed and manufactured in the US. The FDA Licensing Process involves submitting a license application to the FDA Technology Transfer Program, which reviews the technology, negotiates a mutually acceptable agreement, and monitors the reporting requirements 1. The FDA Licensing Process can be used for different types of licenses, such as non-exclusive, exclusive, biological materials, or commercial evaluation licenses.
Medical License: This is the route for licensing individual practitioners who want to prescribe or administer medicines in the US. Medical licenses are granted by individual states, and only those with medical degrees from schools listed in the World Directory of Medical Schools are permitted to apply 2. Medical licenses are separate from board certifications, which are voluntary and indicate a higher level of expertise in a specialty.
Importing Pharmaceuticals: This is the route for licensing medicines that are produced outside the US and need to be imported into the country. Importing pharmaceuticals requires complying with both the FDA and the CBP (Customs and Border Protection) regulations, which include submitting the product for FDA approval prior to import, providing advance notification of pending shipment, and paying any applicable fees or duties 3. Importing pharmaceuticals also requires following the rules of the country of origin and the country of destination, which may vary depending on the product and the trade agreements.
Compulsory Licensing: This is a rare and controversial route for licensing medicines that are patented by another entity, but are deemed necessary for public health or national security reasons. Compulsory licensing allows a government to license companies or individuals other than the patent owner to use the rights of the patent, without the permission of the patent owner 4. Compulsory licensing is usually done in cases of emergencies, such as pandemics, wars, or natural disasters, and requires paying a reasonable royalty to the patent owner.
There are also some accelerated approval routes for licensing medicines that are intended to treat serious or life-threatening conditions, and provide a significant improvement over existing therapies. Some of the accelerated approval routes are:
Fast Track: This is a designation that expedites the review and development of drugs that address an unmet medical need. Fast Track drugs are eligible for more frequent meetings and communications with the FDA, rolling review of the application, and priority review .
Breakthrough Therapy: This is a designation that applies to drugs that demonstrate substantial improvement over existing therapies in one or more clinically significant endpoints. Breakthrough Therapy drugs are eligible for all the benefits of Fast Track, as well as intensive guidance from the FDA on the development plan and the design of clinical trials .
Accelerated Approval: This is a pathway that allows the approval of drugs based on surrogate or intermediate endpoints, which are indicators that are reasonably likely to predict clinical benefit. Accelerated Approval drugs are subject to confirmatory trials after approval, and may be withdrawn if the benefit is not confirmed or the risk-benefit balance is unfavorable .
Priority Review: This is a designation that shortens the review time of drugs that offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Priority Review drugs have a target review time of 6 months, compared to 10 months for standard review .
I hope this information helps you understand the various routes for licensing medicines in the US. If you have any further questions, please feel free to ask.

1. fda.gov
2. en.wikipedia.org
3. usacustomsclearance.com
4. csis.org

Here is a brief overview of the main routes for licensing medicines in the US:
Standard Review: The typical process for new drug approval, which involves preclinical testing, three phases of clinical trials, and FDA review. Usually takes several years.
Priority Review: For drugs that treat serious conditions and offer major advances in treatment. Shortens the FDA review timeline from 10 months to 6 months.
Accelerated Approval: Allows approval based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Still requires post-approval confirmatory trials. Often used for serious conditions with unmet need.
Fast Track: Facilitates development and expedites review of drugs for serious conditions with unmet need. Allows rolling submission of sections of NDA.
Breakthrough Therapy: Expedites development and review of drugs showing substantial improvement over available therapy in Phase 2 trials. Intense FDA guidance and communication.
Orphan Drug: Incentivizes development of drugs for rare diseases affecting <200,000 people. 7 years of marketing exclusivity upon approval.
Pediatric Exclusivity: Grants 6 months of patent extension for studying drug in pediatric populations.
In summary, the FDA offers various mechanisms to expedite and incentivize development of drugs that address unmet medical needs. Accelerated approval pathways trade earlier access for completing post-approval requirements.		In the US, there are several routes for licensing medicines, including accelerated approval routes. Here is a synopsis of each route:
1. Investigational New Drug (IND): Before a drug can be transported or distributed across state lines, it must be the subject of an approved marketing application. The IND is the means through which the sponsor technically obtains this exemption from the FDA. The IND is used to test the drug in clinical trials to determine its safety and effectiveness2.
2. New Drug Application (NDA): When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet FDA’s requirements for marketing approval, the sponsor submits to FDA an NDA. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States2.
3. Biologics License Application (BLA): Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A BLA is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biologic product. If the information provided meets FDA requirements, the product may be marketed in the US2.
4. Accelerated Approval: This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval. Many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course. For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm 1.

In addition to these routes, there are also national and centralized routes for authorizing medicines in the European Union 3. It is important to note that the choice of routes in which medications are applied depends not only on convenience but also on the drug’s properties and pharmacokinetics 6.

1. Development & Approval Process | Drugs (FDA)

2. Types of Applications

3. Authorisation of Medicines (EMA)

4. Code of Federal Regulations (US)

5. Code of Federal Regulations (US)

6. Medication Routes of Administration (National Library of Medicine, US)
Note:
Only responses from ChatGPT 3.5 and Claude.ai mention Orphan registration as a licensing route		Note:
The response from Microsoft Copilot with Bing Chat does not even mention the main routes of licensing e.g. NDA, BLA etc.

Only the responses from Microsoft Copilot with Bing Chat And Perplexity.ai include references.
Note:
Only responses from ChatGPT 3.5 and Claude.ai mention Orphan registration as a licensing route		Note:
1) Only the responses from Microsoft Copilot with Bing Chat And Perplexity.ai include references.

2) The response from Perplexity.ai lists six references but only three are referenced in the response.

3) The response from Perplexity.ai incorrectly lists Investigational New Drug (IND) as a route route of licensing.
Oddly, the response also refers to routes of licensing in the EU even though this was not part of the question.

Google Bard
Draft 1		Google Bard
Draft 2		Google Bard
Draft 3		Zephyr 7b Beta Chat
Routes for licensing medicines in the US
The US Food and Drug Administration (FDA) is responsible for regulating the safety and efficacy of medicines before they can be marketed in the US. There are two main routes for licensing medicines in the US:

· Standard review: This is the most common route and involves a thorough review of all of the data submitted by the sponsor, including preclinical data, clinical trial data, and manufacturing information. The FDA may also request additional data or studies during the review process. The standard review process can take up to 10 months, but it is often longer.
· Priority review: The FDA grants priority review to medicines that have the potential to address an unmet medical need or that offer significant improvement over existing therapies. Priority review applications are typically reviewed within 6 months.

Accelerated approval routes
The FDA also offers a number of accelerated approval routes for medicines that treat serious or life-threatening diseases and that fill an unmet medical need. These accelerated approval routes are designed to get safe and effective medicines to patients more quickly.
The following are some of the accelerated approval routes available in the US:

· Breakthrough Therapy Designation: The FDA grants Breakthrough Therapy Designation to medicines that have the potential to provide a substantial improvement over existing therapies for serious or life-threatening diseases. Medicines with Breakthrough Therapy Designation are eligible for expedited development and review, and they may be eligible for rolling review, which allows the FDA to review data from ongoing clinical trials as it becomes available.

· Fast Track Designation: The FDA grants Fast Track Designation to medicines that are intended to treat a serious or life-threatening condition and that have the potential to address an unmet medical need. Medicines with Fast Track Designation are eligible for expedited development and review, and they may be eligible for rolling review.

· Accelerated Approval: The FDA may grant accelerated approval to medicines that are intended to treat a serious or life-threatening condition and that fill an unmet medical need. Accelerated approval is based on a surrogate endpoint, which is a biomarker or other measure that is reasonably likely to predict clinical benefit. Medicines granted accelerated approval must be verified in a confirmatory clinical trial.

The following table provides a synopsis of each route for licensing medicines in the US, including accelerated approval routes:

Route: Standard review
Description: Thorough review of all data submitted by the sponsor
Timeline: Up to 10 months, but often longer

Route: Priority review
Description: Expedited review for medicines that address an unmet medical need or offer significant improvement over existing therapies
Timeline: 6 months

Route: Breakthrough Therapy Designation
Description: Expedited development and review for medicines that have the potential to provide a substantial improvement over existing therapies for serious or life-threatening diseases
Timeline: May be eligible for rolling review

Route: Fast Track Designation
Description: Expedited development and review for medicines that are intended to treat a serious or life-threatening condition and that have the potential to address an unmet medical need
Timeline: May be eligible for rolling review

Route: Accelerated Approval
Description: Expedited development and review for medicines that are intended to treat a serious or life-threatening condition and that fill an unmet medical need
Timeline: Based on a surrogate endpoint; must be verified in a confirmatory clinical trial

It is important to note that the FDA does not guarantee approval of any medicine, regardless of the route that is taken. The FDA will only approve medicines that have been shown to be safe and effective.


Notes:
For the last part of this response, Bard provided a table. The information is provided above in an untabulated format as it was not possible to insert a table within a table



There are two main routes for licensing medicines in the US:

1. Standard review: This is the most common route and takes about 10 months to complete. It involves submitting a New Drug Application (NDA) to the Food and Drug Administration (FDA) that contains all of the data on the safety and efficacy of the medicine.

2. Priority review: This route is available for medicines that have the potential to treat serious or life-threatening illnesses or conditions, or that meet an unmet medical need. Priority reviews take about 6 months to complete.

In addition to these two main routes, there are a number of accelerated approval routes that are available for medicines that meet certain criteria. These routes include:
· Fast Track: This program is designed to expedite the development and review of new drugs that address unmet medical needs in patients with serious or life-threatening conditions.
· Breakthrough Therapy: This designation is for new drugs that have the potential to provide a substantial improvement over available therapies for serious or life-threatening conditions.
· Accelerated Approval: This pathway allows the FDA to approve a new drug for marketing based on a surrogate endpoint, which is a marker of clinical benefit other than direct clinical improvement (such as tumor shrinkage or viral load reduction).
· Pediatric Priority Review Voucher (PPV): This program is designed to incentivize the development of new drugs for children. A company that receives a PPV can redeem it to receive a priority review for a subsequent NDA.

Synopsis of each route:
Standard review:
· The applicant submits an NDA to the FDA.
· The FDA reviews the NDA for safety and efficacy.
· The FDA may request additional data from the applicant.
· If the FDA approves the NDA, the applicant is granted a marketing authorization.

Priority review:
· The applicant submits an NDA to the FDA and requests a priority review.
· The FDA reviews the NDA for safety and efficacy.
· The FDA may request additional data from the · applicant.
· If the FDA approves the NDA, the applicant is granted a marketing authorization.

Fast Track:
· The applicant submits a Fast Track request to the FDA.
· The FDA reviews the request and determines whether to grant Fast Track designation.
· If the applicant is granted Fast Track designation, the FDA will work with the applicant to expedite the development and review of the drug.

Breakthrough Therapy:
· The applicant submits a Breakthrough Therapy request to the FDA.
· The FDA reviews the request and determines whether to grant Breakthrough Therapy designation.
· If the applicant is granted Breakthrough Therapy designation, the FDA will work with the applicant to expedite the development and review of the drug.

Accelerated Approval:
· The applicant submits an NDA to the FDA and requests accelerated approval.
· The FDA reviews the NDA and determines whether to grant accelerated approval.
· If the FDA grants accelerated approval, the applicant is granted a marketing authorization.
· The applicant must also conduct postmarketing studies to confirm the clinical benefit of the drug.

Pediatric Priority Review Voucher (PPV):
· The applicant submits a PPV request to the FDA.
· The FDA reviews the request and determines whether to grant a PPV.
· If the applicant is granted a PPV, the applicant can redeem it to receive a priority review for a subsequent NDA.

I hope this synopsis is helpful. Please let me know if you have any other questions

Note:
Only this response mentions the Pediatric Priority Review Voucher (PPV):		There are three main routes for licensing medicines in the US:

· Standard Review: This is the most common route, and it typically takes 10-12 months for a marketing application to be reviewed and approved.

· Priority Review: This route is available for medicines that are intended to treat serious or life-threatening conditions, or that offer a significant improvement over existing treatments. Priority Review applications are typically reviewed within 6 months.

· Accelerated Approval: This route is available for medicines that treat serious or life-threatening conditions, and that meet certain other criteria. Accelerated Approval applications can be approved based on surrogate endpoints, which are measures of a drug’s effect that are thought to reasonably predict clinical benefit. Post-approval studies are then required to confirm clinical benefit.

In addition to these three main routes, there are also a number of accelerated approval routes for specific types of medicines, such as:

· Fast Track: This program is designed to facilitate the development and review of medicines that address unmet medical needs.

· Breakthrough Therapy: This program is designed to expedite the development and review of medicines that may treat a serious or life-threatening condition, and that have preliminary clinical evidence that demonstrates substantial improvement over existing treatments.

· Regenerative Medicine Advanced Therapy (RMAT): This program is designed to expedite the development and review of regenerative medicine therapies that treat serious or life-threatening diseases and conditions.

Synopsis of each route:
Standard Review: Applicants submit a new drug application (NDA) to the FDA, which contains data from preclinical and clinical studies to support the safety and efficacy of the medicine. The FDA reviews the NDA and may ask for additional information. If the FDA approves the NDA, the applicant is granted a marketing authorization and can begin selling the medicine in the US.

Priority Review: Applicants submit a request for Priority Review along with their NDA. The FDA will grant Priority Review if the medicine meets the criteria for this program. Priority Review applications are reviewed within 6 months, compared to the standard review timeline of 10-12 months.

Accelerated Approval: Applicants submit a request for Accelerated Approval along with their NDA. The FDA will grant Accelerated Approval if the medicine meets the criteria for this program. Accelerated Approval applications can be approved based on surrogate endpoints, which are measures of a drug’s effect that are thought to reasonably predict clinical benefit. Post-approval studies are then required to confirm clinical benefit.

Fast Track: Applicants submit a written request for Fast Track designation to the FDA. The FDA will grant Fast Track designation if the medicine meets the criteria for this program. Fast Track designation does not guarantee approval, but it does give the applicant early access to the FDA’s expertise and guidance.

Breakthrough Therapy: Applicants submit a written request for Breakthrough Therapy designation to the FDA. The FDA will grant Breakthrough Therapy designation if the medicine meets the criteria for this program. Breakthrough Therapy designation gives the applicant early access to the FDA’s expertise and guidance, and it also makes the medicine eligible for certain other programs, such as Priority Review and Rolling Review.

Regenerative Medicine Advanced Therapy (RMAT): Applicants submit a written request for RMAT designation to the FDA. The FDA will grant RMAT designation if the medicine meets the criteria for this program. RMAT designation gives the applicant early access to the FDA’s expertise and guidance, and it also makes the medicine eligible for certain other programs, such as Priority Review and Rolling Review.
It is important to note that all medicines, regardless of the route used for licensing, must meet the same high standards of safety and efficacy. The FDA carefully reviews all data submitted by applicants before making a decision about whether to approve a medicine.

Note:
Only this response mentions the Regenerative Medicine Advanced Therapy (RMAT):


In the United States, there are several paths to license (also known as “approve”) new drugs and biologics:
1. New Drug Application (NDA): This is the standard pathway for licensure of small molecule drugs that have not been previously approved by the FDA. The NDA process typically takes around 10-24 months from submission to approval. Applicants must provide preclinical and clinical data demonstrating safety and efficacy. If a drug has unique properties or targets an unmet medical need, it may be eligible for priority review, which reduces the review time to six months.
2. Biological License Application (BLA): Similar to an NDA, but specific to biological products such as vaccines, blood derivatives, and recombinant DNA products. BLA submissions follow similar requirements to those of NDAs. Priority review can also apply to BLAs.
3. Abbreviated New Drug Application (ANDA): For generic versions of previously approved brand name medications. ANDA applications require bioequivalence studies showing that the proposed generic version has equivalent absorption, distribution, metabolism, and excretion (ADME) profiles to the original drug. Approval timelines generally range from two to four years due to backlogged reviews.
4. Fast Track Designation: Allows for more frequent communication with the FDA throughout development, rolling submissions, and eligibility for priority review vouchers. To qualify, the candidate drug must treat a serious condition and demonstrate potential advantages over existing therapies based on preliminary evidence.
5. Breakthrough Therapy Designation: Intended for drugs addressing life-threatening conditions where preliminary clinical evidence indicates substantial improvement over available treatments. It provides intensive guidance and assistance from the FDA, expedited development meetings, and priority review.
6. Regenerative Medicine Advanced Therapy (RMAT): Accelerates development and review processes for regenerative medicine, cell, and gene therapy candidates. Eligible products can receive priority review, streamlined manufacturing application requirements, and rolling submission opportunities.
7. Rare Pediatric Disease Designation: Encourages developers to focus resources on rare diseases affecting children through tax credits, priority review, and regulatory fee waivers.
8. Accelerated Approval: Can allow marketing authorization based on surrogate endpoints (a marker thought to predict clinical benefit), such as tumor shrinkage instead of overall survival in cancer treatment, when there is an urgent public health need. Postmarketing confirmatory trials will then be required to verify the product’s effectiveness.
9. Expedited Programs for Serious Conditions: A combination of initiatives designed to speed up the availability of safe and effective treatments for patients facing grave illnesses. These programs include Fast Track, Breakthrough Therapy, Priority Review Voucher, RMAT, and Regulatory Science Initiative designations.

Note that some drugs may qualify for multiple designations simultaneously if they meet the criteria for all paths. Each program requires meeting certain criteria and ongoing compliance with specified guidelines during development./
Note:
Only the Draft 2 response from Google Bard and the response from Zephyr 7B Beta mention the Paediatric Priority Review Voucher		Note
Only Draft 3 of the Google Bard response and the Zephyr 7B beta chat response mention the Regenerative Medicine Advanced Therapy (RMAT) program		Note
1) Note:
Only the Draft 2 response from Google Bard and Zephyr 7B Beta response mention the Paediatric Priority Review Voucher

2) Only Draft 3 of the Google Bard response and the Zephyr 7B beta chat response mention the Regenerative Medicine Advanced Therapy (RMAT) program