Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science 40

Science FDA Packaging Production 40

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) recommendation that the Drug Enforcement Administration (“DEA”) reschedule cannabis federally from schedule I to schedule III would lead an outsider to conclude that commenters are referring to different substances. Letter to U.S.

Regulations 59

Regulations Production FDA Approval Marketing 59

Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” 341 (2001). See 42 U.S.C. § See 21 C.F.R.

FDA 59

FDA FDA Approval Licensing Licensing 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

FDA 59

FDA FDA Approval Testimonials Vaccine 59