RAPS Highlights

 

 

 

 

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...

05 July 2022 | By Joanne S. Eglovitch
Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition

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

05 July 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: TGA updates uniform recall procedure

Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration ...

01 July 2022 | By Michael Mezher
This Week at FDA: User fee timeline, bivalent boosters, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device...

01 July 2022 | By Joanne S. Eglovitch
FDA tells Dutch API producer to clean up its equipment act

A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and...