Agency IQ

OCTOBER 6, 2023

FDA’s approval volume seems to have recovered from a dip in FY 2022, driven mostly by biologics Now that the government’s – and the FDA’s – fiscal year has come to a close, AgencyIQ has reviewed all novel drug approvals for FY 2023. government fiscal year runs from October 1 – September 30.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. That means that thousands of FDA staff are likely to be furloughed in early October, and potentially for weeks.

FDA 40

FDA Science Regulations Production 40

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

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

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