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...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

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 Seeks Feedback on Mandatory use of QR Codes on API Packaging

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The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...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...
ANSM : Antibiotiques et Résistance Bactérienne : Une Menace Mondiale, des Conséquences Individuelles

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...