Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

Science FDA Packaging Production 40

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

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. A few weeks ago, we reported on Chong v. 343-1(a)(5)).

Regulations 52

Regulations FDA Packaging FDA Approval 52