Extrapolations from pivotal trial data influenced clinical indications in a fifth of the FDA drug approvals examined in a new study. Source: Drug Industry Daily

The FDA’s Office of Generic Drugs (OGD) has revised its manual on bioavailability and bioequivalence studies. Source: Drug Industry Daily

The FDA’s Center for Drug Evaluation and Research (CDER) has issued draft guidance for industry on developing medicines that can be used for the treatment of celiac disease (CeD) along…

The Federal Trade Commission (FTC) is extending the public comment period by a month on a request for information centering on the business practices of pharmacy benefit managers (PBMs). Source:…

The FDA has finalized its guidance on oral drug bioavailability (BA) studies, outlining its current recommendations for study designs, alternative approaches and other areas. Source: Drug Industry Daily

The FDA intends to revoke Protagonist Therapeutics’ Breakthrough Therapy designation for rusfertide as a treatment for a rare blood cancer that causes bone marrow to produce excess red blood cells,…

A bipartisan group of lawmakers from both chambers sent letters to seven drugmakers urging them to seek FDA approval for over-the-counter (OTC) versions of their naloxone drugs. Source: Drug Industry…

It’s official: The public health emergency (PHE) that is COVID-19 will continue for at least three more months. Source: Drug Industry Daily

The FDA has extended by three months its review of Regeneron Pharmaceuticals’ Biologics License Application (BLA) for its antiviral drug REGEN-COV (casirivimab plus imdevimab) for full approval as a preventive…

A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or…