USA – FDA issues 80 guidances for topical products
The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or...
USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
USA – FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19...
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect...
USA – Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA
The current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months...
USA – Stakeholders concerned with FDA’s definition of labeling in PDURS guidance
Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription...
USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests
Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the...
USA – Califf: FDA committed to boosting complex generic drug development
Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval...
USA – CERSI Summit: Wider use of real-world evidence continues to face hurdles
The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect...
USA – FDA issues guidance on developing long-acting local anesthetics
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...
