USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated...
International – ICH M11 guideline, clinical study protocol template and technical specifications
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a...
Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
EMA’s human medicines committee (CHMP) has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations....
USA – Postmarketing requirements: FDA drafts guidance on determining non-compliance
The US Food and Drug Administration (FDA) has released a draft guidance for sponsors on how the agency determines an applicant has demonstrated good...
Europe – EMA offers insights on when biologics qualify as new active substances
The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins
The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5...
Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA...
