Canada – Special Access Program for drugs: Guidance document for industry and practitioners

This guidance document explains the regulatory information requirements and conditions for practitioners and manufacturers when drugs are requested through the Special Access Program (SAP)....

USA – Digital health tech in clinical investigations: FDA issues draft guidance

The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish...

USA – FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing...
Nitrosamine contamination: new web page on EDQM response

Europe – Pharmeuropa 34.1 just released

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.1 is 31 March...

France – Dépakine : Sanofi jugé responsable d’un manque de vigilance et d’information sur...

Le tribunal judiciaire de Paris a estimé, mercredi 5 janvier, que le groupe pharmaceutique français Sanofi avait « commis une faute en manquant à son obligation de...

UK – MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the use of a second oral antiviral pill for COVID-19 to be taken at...

International – ICH releases revised Q9 guideline to improve risk assessments

The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of...

Europe – Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

The European Commission has set out how it plans to stop Brexit from disrupting the supply of drugs in certain markets, most notably Northern...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – The past, the present, and the future of clinical trials transparency in...

The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has...

France – Arrêté du 25 octobre 2021 fixant le règlement intérieur type des CPP

Le règlement intérieur qui régit l'organisation et le fonctionnement des comités de protection des personnes au plan technique et administratif doit être établi par...

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