New drug options, risk factors added to U.S. heart guidelines

USA – New drug options, risk factors added to U.S. heart guidelines

Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at...
FDA approves first PI3K inhibitor for breast cancer

USA – FDA approves first PI3K inhibitor for breast cancer

Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA authorizes Gilead’s remdesivir for emergency use

The US Food and Drug Administration (FDA) on Friday issued an emergency use authorization (EUA) allowing the use of Gilead Sciences’ remdesivir to treat...
Drugmakers Call for Changes, Additions to FDA’s Purple Book

USA – Drugmakers Call for Changes, Additions to FDA’s Purple Book

The US Food and Drug Administration’s (FDA) Purple Book for biosimilars needs some modifications and new information to be more useful, pharmaceutical companies told...
FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says

USA – FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says

The US Food and Drug Administration (FDA) on Thursday unveiled a new framework discussing how the agency will use real world evidence (RWE) and...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA enhances DDT qualification pathway for biomarkers

The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with...

USA – US regulations for regenerative medicine advanced therapies

This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that...
FDA seeks ways to promote individualized therapies

USA – FDA Finalizes Testicular Toxicity Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a...
Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

USA – Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting...

The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

USA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including...

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