USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
The candidate, ACI-24.060, will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate...
USA – FDA adds microbiological assessments to ophthalmic drug quality guidance
The US Food and Drug Administration (FDA) recently issued a revised draft guidance for topical ophthalmic drugs recommending that manufacturers follow certain microbial testing...
International – WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials....
Europe – EMA addendum addresses vaccine development for immunocompromised people
The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised...
USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
UK – Eli Lilly’s Mounjaro receives NICE recommendation to treat type 2 diabetes
According to NICE’s draft guidance, around 180,000 people living with difficult-to-manage type 2 diabetes could benefit from the new treatment option.
The recommendation follows additional...
USA – FDA finalizes guidance on real-world evidence in drug approvals
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in...
UK – NICE nod for AstraZeneca’s Lynparza
Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer
The National Institute for Health and Care Excellence (NICE) has recommended...
UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that...
Exceptions and modifications document – updates (01 Jan 2025)
-Overall updates were made to the document to reflect changes to UK legislation implementing new arrangements...
