Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.
Posted: September 24, 2021, 7:15 pm
The US Food and Drug Administration is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.
Posted: September 24, 2021, 6:43 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: September 24, 2021, 5:22 pm
The process used by the US Food and Drug Administration to vet new drugs and biologics is inconsistent in borderline cases and fails to rely on evidence standards used in previous decisions, according to findings from a case series that examined the process across 22 "close call" applications in recent years.
Posted: September 23, 2021, 9:13 pm
Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one of the led the US Food and Drug Administration (FDA) to issue two warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.
Posted: September 23, 2021, 7:50 pm