RAPS Highlights





06 December 2022 | By Ferdous Al-Faruque
MDCG offers clarity on ‘hybrid’ audits under MDR, IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified...

06 December 2022 | By Ferdous Al-Faruque
FDA Class I device recall events ticked up in FY 2022

While the total number of the most serious medical device recalls in the US has declined in recent years, the number of recall event...

06 December 2022 | By Joanne S. Eglovitch
Recon: Neuralink faces federal probe over animal tests; Emergent nabs priority review for OTC opioid overdose drug

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

06 December 2022 | By Michael Mezher
FDA warns Glenmark over GMP, laboratory control issues

The US Food and Drug Administration (FDA) warned Indian generic drugmaker Glenmark Pharmaceuticals Limited for several good manufact...

06 December 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: New Zealand’s Medsafe retains classification of low-dose CBD

In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regula...