UK – MHRA safety review of medicines containing pseudoephedrine
Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and...
International – ICH releases draft guideline proposing harmonized bioequivalence testing
The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release...
International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
The committee recommended granting a conditional...
Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines
EMA’s safety committee (PRAC) has recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines.
The recommendation follows a review which found that measures to restrict...
USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA...
The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User...
Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance...
