RAPS Highlights





21 October 2021 | By Michael Mezher
FDA withdraws more than 200 ANDAs over unsubmitted annual reports

Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeated...

21 October 2021 | By Joanne S. Eglovitch
Continuous manufacturing bill clears House

The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation...

21 October 2021 | By Mary Ellen Schneider
HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures

US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump A...

21 October 2021 | By Nick Paul Taylor
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into re...

21 October 2021 | By Michael Mezher
Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

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