RAPS Highlights

 

 

 

 

11 August 2022 | By Joanne S. Eglovitch
FDA blasts California firm for multiple GLP issues involving nonclinical studies

The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinica...

11 August 2022 | By Joanne S. Eglovitch
Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine

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

11 August 2022 | By Mary Ellen Schneider
FDA-led study highlights tradeoffs in drug promotion on social media

Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twit...

11 August 2022 | By Nick Paul Taylor
Euro Roundup: MDCG posts guidance on notified bodies

MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro ...

10 August 2022 | By Ferdous Al-Faruque
FDA Official: EU privacy regulations impede BIMO inspections, application reviews

According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers...