Remove 2024 Remove Biosimilars Remove Packaging Remove Testimonials
article thumbnail

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). If none of the 12 bills are completed, then all government operations shut down.

article thumbnail

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

Agency IQ

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

FDA 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

Agency IQ

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 40
article thumbnail

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40