Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...
EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...
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....
International – Pfizer doses first patients with mRNA-based influenza vaccine
Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically offer only 40% to 60% protection, with...
USA – FDA issues final rule on ‘right to try’ reporting requirements
Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
India – Indian Pharmacopoeia joins global discussion group pilot
The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters
To help better track submissions that include real-world data (RWD) and real-world evidence (RWE), the US Food and Drug Administration (FDA) is asking drug...
France – ANSM : Pholcodine : Suspension des autorisations de mise sur le marché...
Les autorisations de mise sur le marché de tous les médicaments à base de pholcodine sont suspendues à compter du 8 septembre 2022, à...
Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to comply with the EU’s GMP Annex 1...