The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Read More
The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS). Read More
“We were delighted to be one of the first companies to work with the PRIMA service, and collaborate with NICE on improving this valuable tool,” said Peter Wheatley-Price, Takeda UK’s market access and pricing director. Read More
The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility for the program that provides early scientific and regulatory support for medicines based on promising preliminary clinical evidence. Read More