USA – FDA updates generic transdermal and topical delivery systems guidances
The US Food and Drug Administration (FDA) on Wednesday issued two revised draft guidances for generic drug submissions that use transdermal and topical delivery...
USA – FDA outlines risk-based approach to monitoring clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring...
France – L’ANSM suspend la commercialisation des produits Trex Tea, Trex Caps et Trex...
Nous avons été informés par le réseau des centres régionaux de pharmacovigilance et les centres anti-poison et de toxicovigilance de nombreux effets indésirables chez...
USA – FDA updates guidance on reporting manufacturing disruptions for finished products and APIs
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or...
International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing...
USA – FDA withdraws pre-term birth drug Makena
Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena...
USA – FDA issues last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
UK – Ipsen reacts to NICE’s Cabometyx verdict
Ipsen has expressed its disappointed regarding the National Institute for Health and Care Excellence’s (NICE) preliminary guidance which does not recommend Cabometyx – also...
