PRAC concludes Picato’s risks are greater than its benefits.

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

In collaboration with the national network of pharmacovigilance centers (CRPV), the ANSM has set up continuous monitoring of adverse effects linked to the use of medicines in patients with COVID-19.

As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF).

The European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

Submission to the ANSM as part of a clinical trial requiring adaptation in connection with COVID-19: Substantial Modification Submission to: ams-essaiscliniques@ansm.sante.fr Attention: it is imperative to name the email mentioning: “MSA-COVID-19 / Type of trial / Trial Phase N° /…

Eight new medicines recommended for approval

Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The COVID-19 pandemic has an immediate impact on the conduct of clinical trials. The availability of research site staff in the context of overcrowding must be taken into account, as must national containment rules.

The U.S. FDA has published a new Guidance Document on 19-Mar-2020, which is entitled : “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”.