USA – Global regulators discuss how they are adapting to AI, real-world data in...

Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say...

USA – FDA to require new safety warnings for opioids

The US Food and Drug Administration (FDA) last week announced new labeling updates and safety warnings for immediate-release (IR) and extended-released/long acting (ER/LA) opioids...

UK – AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer

The anti-cancer medicine will now be routinely available for adults with HER2-negative, high-risk early breast cancer who have inherited faults in their BRCA1 or...

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...
New guidance on biologics affects authorized generics

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...
Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance

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The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or...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)...
WHO drafts guidance for pharma supply chain tracking

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...

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