medicines-medical devices-regulatory affairs
The U.S. FDA today announced the final design of the Expedited Investigational New Drug (IND) Pilot. What does the pilot aim to achieve? Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 2 Sep 2026 Evaluation of Therapeutic Equivalence This guidance provides information regarding FDA’s therapeutic equivalence…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 25 Jun 2026 Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level…
The U.S. FDA announced actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. The FDA’s work is outlined in Operation TrialBlazer, a U.S. Department of Health and Human Services (HHS) initiative. …
Date Title of guidance and link to document Type and levelof guidance About the guidance 27 Mar 2026 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Final This guidance provides recommendations on how voluntary “patient preferenceinformation” (PPI)…
Date Title of guidance and link to document Type and levelof guidance About the guidance 17 Dec 2025 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Medical Devices) Further reading:FDA finalizes real-world evidence guidance for device sponsors,…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Sep 2025 E20 Adaptive Designs for Clinical Trials Draft, Level 1 This document provides guidance on confirmatory clinical trials with an adaptive design intended…
On 3 September 2025, FDA’s CDER and CBER proposed a new process under Rare Disease Evidence Principles (RDEP) to facilitate the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need and with…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2025 (Medical Devices) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final This guidance is applicable to devices with…
Date Title of guidance and link to document Type and levelof guidance About the guidance 5 Feb 2025 Institutional Review Boards Frequently Asked Questions Final This a compilation of answers to questions asked of FDA regarding the protection of human…