NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing

USA – NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing

The National Comprehensive Cancer Network (NCCN) has released updated guidelines on the use of immunotherapy to treat non–small-cell lung cancer (NSCLC), including recommendations on the use...
FDA Promises Flexibility for Stem Cell Trials

USA – FDA Promises Flexibility for Stem Cell Trials

Regulators are promising “flexibility” in clinical trial design for stem cell therapies for rare diseases. In a final guidance, the FDA says it “recognizes that,...
Natural History Studies for Rare Diseases: FDA Drafts Guidance

USA – Natural History Studies for Rare Diseases: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Friday published new draft guidance to help inform the design and implementation of natural history studies...
NICE nod for Takeda’s Adcetris in advanced stage CTCL

UK – NICE nod for Takeda’s Adcetris in advanced stage CTCL

The indication is for treating adult patients with CD-30 positive advanced versions of the disease, after at least one prior systemic therapy. The approval...
EMA Management Board: highlights of March 2019 meeting

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 Finalizes Two Guidances on HIV Drug Development

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...
Australian manufacturing licences and overseas GMP certification

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...

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