Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The CHPA presenters described “issues and misconceptions” with the FDA analysis. billion, compared with retail sales of $0.5

Science 40

Science FDA Clinical Trials Pharmacy 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). 2003); Birdsong v.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. 644 (2003), but not to Pike. Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

Regulations 59

Regulations Production FDA FDA Approval 59