.jpg.aspx?lang=en-US&width=300&height=200&ext=.jpg?maxsidesize=100)
MDCG guidance aims to h…
The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a to help the medical device i…
Study: Blockbuster, acc…
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated a…
FDA takes steps to rela…
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regu…
This Week at FDA: House…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug …
Asia-Pacific Roundup: N…
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in l…
FDA, EMA officials disc…
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform appr…
Study: Novel drug appro…
More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by …
FDA works to advance re…
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to…
IVDR: Commission adds r…
The European Commission last week updated its list of officially recognized harmonized standards for diagnostics i…
This Week at FDA: House…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug …
Euro Convergence: Atten…
Corrected 13 May 2022* AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authori…
500+ gather in Amsterda…
RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam aft…
