PRAC recommendations on signals

Europe – EMA Management Board: highlights of March 2019 meeting

EMA’s Management Board has re-elected Christa Wirthumer-Hoche as its chair for a three-year mandate. Dr Wirthumer-Hoche is Head of the Austrian Medicines and Medical Devices Agency,...
FDA’s OCP Works to Modernize Review Functions

USA – FDA’s OCP Works to Modernize Review Functions

Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP)...
Applying human factors to nicotine replacement therapy drug products

USA – Applying human factors to nicotine replacement therapy drug products

US regulators reevaluating how to oversee nicotine replacement therapy (NRT) products; NRT manufacturers should utilize human factors in developing NRT product labels; Self-selection...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare...
FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

USA – FDA Finalizes Two Guidances on HIV Drug Development

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents to support the development of antiretroviral drug products for the treatment...
TGA Creates Guidance on Device Standards for Quality Management Systems

Australia – Australian manufacturing licences and overseas GMP certification

This step-by-step guide is for: Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic...
A Right Royal Deadlock: Can "Crown" use unlock patented drug?

UK – A Right Royal Deadlock: Can « Crown » use unlock patented drug?

Following a two year deadlock between the NHS and Vertex Pharmaceuticals, the NHS, in July 2018, offered to make the 'largest ever' financial commitment...
FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

USA – FDA suggests letting more patients with viral infections into cancer clinical trials

On the pages of oncology clinical trials on the database ClinicalTrials.gov, the section listing the various criteria that patients must meet for enrollment commonly...
FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

USA – FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely...
Health Canada Begins Release of Clinical Data on Drugs and Devices

Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices

Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and...

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