USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency...
USA – FDA’s drug approvals in 2022
Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. This is a drop from the highs of the...
USA – FDA finalizes guidance on REMS format and content
The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
USA – Provider groups, researchers raise concerns about extrapolating adult data in children
Clinicians and researchers are voicing concerns that the US Food and Drug Administration (FDA) has overemphasized the role for extrapolating adult data in pediatric...
USA – Drugmakers, advocacy groups ask FDA to clarify expanded access draft guidance
Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently...
USA – CDER chief: Improving clinical trials is on to-do list
Encouraging researchers and sponsors to simplify clinical trials and employ a fit-for-purpose protocol is one way that the US Food and Drug Administration (FDA)...
USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – FDA issues draft guidance on dosage and administration labeling
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...
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...
