USA – FDA launches new Quantitative Medicine Center of Excellence
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the establishment of a new quantitative medicine (QM)...
USA – FDA reduces number of samples to retain for BA/BE testing
In a part-draft, part-final guidance issued on Tuesday, the US Food and Drug Administration (FDA) finalized its policy on the quantity of reserve samples...
Europe – European Commission proposes updates to medical device phthalates guidelines
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is...
Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn...
New Eealand – New Zealand updates pharmacovigilance guideline
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its guideline on pharmacovigilance after receiving support for changes it proposed late...
Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application...
Europe – EMA Management Board: highlights of March 2024 meeting
EMA annual report 2023
The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which...
France – Paxlovid (nirmatrelvir/ritonavir) : rappel des interactions médicamenteuses avec certains immunosuppresseurs, notamment le...
Paxlovid est indiqué dans le traitement des patients adultes atteints du Covid-19 qui n’ont pas besoin de supplémentation en oxygène et qui présentent un...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
12 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec)...
Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic...
