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The US Food and Drug Administration (FDA) on Friday published new draft guidance to help inform the design and implementation of natural history studies...
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...
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...
FDA suggests letting more patients with viral infections into cancer clinical trials

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...
Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance

USA – Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance

Following the release of five guidances to broaden cancer clinical trial eligibility earlier this week, the US Food and Drug Administration (FDA) is out with draft...

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