medicines-medical devices-regulatory affairs
Title of guidance Type and level of guidance About the guidance Source Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft guidance This guidance: • is intended to assist applicants and holders of an abbreviated new…
The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…
The FDA CDER Export Certificate Program is being modernised, with a move soon to electronic Certificate of a Pharmaceutical Product (eCPPs). Who are the end users of CPPs? Manufacturers exporting products from the U.S. are often asked by foreign customers…
The idea of this post is to provide a snapshot of some milestones in the history of US drug regulation. Medicines regulation is by no means ever perfect but the legislation is constantly evolving. With each evolution, the intent is…