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The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...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...
Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...
EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
UK – MHRA launches new conflicts of interest code of practice for independent advisors
The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new, single code of practice for all its scientific advisory committees, to ensure...
USA – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors...
