FDA Law Blog: Biosimilars

MARCH 29, 2024

That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards.

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Clinical Research FDA Research Clinical Trials 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

Drugs 59

Drugs FDA Hospitals Government 59

Agency IQ

MARCH 1, 2024

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

Government 40

Government FDA Biosimilars Regulations 40

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.

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