RAPS Highlights





06 July 2022 | By Jeff Craven
Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval aft...

06 July 2022 | By Michael Mezher
European Commission adopts common specifications for high-risk IVDs

The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostic...

06 July 2022 | By Mary Ellen Schneider
Health policy experts call for stronger accelerated approval reforms

The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority a...

06 July 2022 | By Joanne S. Eglovitch
Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

05 July 2022 | By Joanne S. Eglovitch
FDA publishes two critical DSCSA draft guidances

The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain...