Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. government fiscal year runs from October 1 – September 30. Despite the growing controversy, the number of products granted accelerated approval increased in FY 2023. As a reminder, the U.S.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. Repeal of this regulation would eliminate an unnecessary policy.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the FDA has appropriated funding through January 19. Expect nearly every company to be closely reading this document when it’s eventually published.

FDA 40

FDA Science Regulations Production 40