FDA seeks expert comments during an upcoming public meeting on strategies to facilitate various centers combining and sharing data.
The US Food and Drug Administration is seeking outside advice to develop its data sharing policies, including those governing sharing within the agency.
FDA officials sometimes combine data sets for research or share them with colleagues internally for various reasons. Since many have...
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The FDA reviewed its efforts to bring PROs into cancer drug development at its 10th annual workshop on clinical outcome assessment in cancer trials.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended Insmed’s Brinsupri and Sanofi’s Wayrilz for pan-EU approval but turned down Sanofi’s Rezurock based on trial results that cast doubt on the drug’s efficacy.
Formal meetings like application orientation sessions or patient listening sessions are becoming increasingly important as the FDA schedules fewer advisory committee meetings for applications, experts said.
Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.
Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.
One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.
