JD Supra

CARES Act Reforms Monograph System For Over-The-Counter Drugs

Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new ...
JD Supra

CARES Act Reforms to Address Drug and Device Shortages and Updates to the OTC Drug Monographs

The CARES Act amends section 506C of the Federal Food, Drug, and Cosmetic Act (FDCA) to require manufacturers of either (1) any “drug that is critical to the public health during a public health ...
The National Law Review

FDA Begins Modernizing its Resources and Implementing Over-The-Counter Monograph User Fee Requirements

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...