USA – FDA CGT draft guidance focuses on potency assurance strategy

The US Food and Drug Administration has proposed a guidance that would update its policy on how sponsors can provide information on potency assurance...

Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the...

On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a...

Europe – ETF warns that monoclonal antibodies may not be effective against emerging strains...

EMA’s Emergency Task Force (ETF) has cautioned that monoclonal antibodies currently authorised for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. These monoclonal antibodies...

International – Novartis confirms death of 2 children after gene therapy

Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention. Two children...

USA – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B

Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...

The following legal obligations apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...

Europe – New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome

On 29 September 2022, EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be...

Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...

This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...

USA – FDA finalizes guidance on adjusting for covariates in randomized trials

The US Food and Drug Administration (FDA) on Friday released a final guidance addressing how sponsors can adjust for covariates in analyzing randomized clinical...