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 ...
Mena FN

FDA Regulation For Over-The-Counter (OTC) Drug Products Webinar: Explore Key Aspects Such As Regulatory Frameworks, Approval Processes, Labeling Requirements, And Compliance ...

(MENAFN- GlobeNewsWire - Nasdaq) The webinar highlights market opportunities in the regulatory landscape for OTC drugs, providing professionals with key insights into FDA requirements, labeling, and ...
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 ...
FierceBiotech

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain ...