USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency...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 – 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 – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia...
USA – FDA offers details on PDUFA VII STAR review pilot
The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten...
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 – FDA outlines process for recognizing standards for regenerative medicines
The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development...
USA – FDA proposes master control trial guidance that goes beyond COVID-19
The US Food and Drug Administration (FDA) this week published a draft guidance on the use of master protocols in clinical trials of drugs...
USA – FDA officials offer advice on gene therapy trials
Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
