International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
UK – NICE publishes final draft guidance recommending three COVID-19 treatments
This includes those who are immunosuppressed, or who have other conditions such as heart disease, respiratory disease, diabetes or neurological disorders.
The agency’s latest guidance...
International – EMA-FDA parallel scientific advice program has ‘limited’ uptake
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the...
Europe – Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs)...
USA – FDA finalizes enforcement policy for FMT treatments
In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota...
France – L’ANSM suspend la commercialisation des produits Trex Tea, Trex Caps et Trex...
Nous avons été informés par le réseau des centres régionaux de pharmacovigilance et les centres anti-poison et de toxicovigilance de nombreux effets indésirables chez...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
USA – FDA updates policies for reviewing ANDAs
The US Food and Drug Administration (FDA) has revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated...
