2016, Biosimilars, Clinical Pharmacology and Licensing

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2016

Biosimilars

Clinical Pharmacology

Licensing

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

December 2023 Clinical Holds in Medical Device Investigations (Proposed Rule) The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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