Lead Story
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
This industry news explores new FDA draft guidance that considers the use of the plausible mechanism framework to develop individualised medicines where randomised controlled trials are not feasible.
Industry news
MHRA seeks views on indefinite acceptance of CE-marked medical devices
This industry news update summarises the MHRA proposals for indefinite recognition of CE-marked medical devices in Great Britain and the potential impact for health systems and patients.
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.
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.
More news
FDA and EMA publish guiding principles of good AI practice in drug development
Saudi FDA vision to be a leading regulator includes updating guidance on combination products
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
