Final NICE guidance issued for Akcea’s Tegsedi

UK – Final NICE guidance issued for Akcea’s Tegsedi

The Highly Specialised Technologies (HST) Guidance is for the treatment of stage I or II polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). It...
Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device...
FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

USA – FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

In a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference on Tuesday, US Food and Drug Administration (FDA) Chief of...
ANSM : Cannabis à visée thérapeutique en France : Les experts poursuivent leurs travaux sur les modalités de mise à disposition

France – ANSM : Cannabis à visée thérapeutique en France : Les experts poursuivent...

Le comité se réunit le 15 mai avec pour objectif de poursuivre le recueil d’informations issues des expériences de pays ayant déjà autorisés l’utilisation...
FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

USA – FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of...
FDA Officials Explain When Litigation Can Impact Drug Safety Signals

USA – FDA Officials Explain When Litigation Can Impact Drug Safety Signals

The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an...
UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a...
FDA opening call center for access to unapproved cancer drugs

USA – FDA opening call center for access to unapproved cancer drugs

Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and...
Fragmin approved by FDA as first anticoagulant for children

USA – Fragmin approved by FDA as first anticoagulant for children

The drug was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The...
Exporting active substance manufactured in the UK in a no deal scenario

UK – Exporting active substance manufactured in the UK in a no deal scenario

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality,...

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