USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks

Fewer than one-third of molecularly targeted cancer drugs recently approved by the US Food and Drug Administration (FDA) meet established European benchmarks for clinical...

USA – FDA turns attention to data integrity lapses at testing sites in new...

The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and...

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...
FDA launches new resource to provide easily accessible, more accurate historical drug approval data

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...
Trois nouvelles guidances du MDCG en Mars 2020

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 Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

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...