USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to...
The US Food and Drug Administration (FDA) has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety...
USA – FDA Approves New Antibiotic for Three Different Uses
Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections...
USA – FDA shifts IND safety reporting over to FAERS in finalized guidance
The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug...
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...
