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 FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science 40

Science FDA Clinical Trials Pharmacy 40

Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. Financial harm,” such as loss of a potential market “is a classic and paradigmatic form of injury in fact.” Sorsaia , 2023 WL 3211847, at *2.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

MAY 26, 2023

The word “generic” in that sentence was not limiting, as the logic applied more broadly: “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.” Id.

Regulations 59

Regulations Production FDA FDA Approval 59