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RAPS Highlights





17 May 2022 | By Joanne S. Eglovitch
FDA, EMA officials discuss impediments to cell and gene therapies

The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developin...

17 May 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry f...

17 May 2022 | By Michael Mezher
Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio

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

17 May 2022 | By Jeff Craven
Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints

More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal t...

16 May 2022 | By Mary Ellen Schneider
FDA works to advance real-world data collection in pregnancy and lactation

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand t...