Lead Story
New ICH M15 Guideline sets harmonised framework for MIDD
This industry news update gives details of the ICH M15 adoption and its aim to establish standardised good practice for the use of evidence derived from model-informed drug development.
Industry news
FDA approves non-invasive device for pancreatic cancer treatment
This industry news update shares details of the FDA’s approval of Optune Pax, a medical device enabling treatment in a home setting.
DIN SPEC 91509: A milestone for structured, digital medical device documentation
This industry news update introduces a new model that will help with the digitalisation of documentation under EU law.
MHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
MHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
FDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
Saudi FDA vision to be a leading regulator includes updating guidance on combination products
This industry news updates shares Saudi FDA’s updated guidance for combination products.
More news
EC proposes regulation to simplify rules on medical and in vitro diagnostic devices
The VMD changes how it calculates adverse events incidents for animals
DARWIN EU reaches more than 100 research studies
EMA launches #ItTakesATeam campaign to address medicine shortages
MHRA advances new reform for the treatment of rare diseases
EMA ETF offers scientific advice for antimicrobial resistance
EMA launches #HealthNotHype campaign
MHRA cuts approval times for UK clinical trials in half
NICE reviews health technology assessment to better support patients
