Drug Discovery World

MARCH 29, 2023

The commission is proposing the introduction of temporary emergency marketing authorisations 1. Extra foreign inspections Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. Allergan Sales , which affirmed a lower court decision in a Federal False Claims case involving best price stacking.

Drugs 59

Drugs Regulations Government Vaccine 59

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 40

FDA Science Regulations Production 40