FDA Related News

FDA General

Biden Nearing His FDA Commissioner Pick

The Biden Administration signals that it is nearing its choice of a nominee for FDA commissioner.

Human Drugs

Bill Could End Animal Testing Mandates

Sens. Paul and Booker introduce legislation to end FDA mandates for animal testing when reliable alternate methods are available.

FDA General

Immunicom Hires Former FDAer Shenouda

Immunicom appoints former FDAer Christian Shenouda as vice president of regulatory affairs.

Human Drugs

Hold on Allogene CAR T Trial Over Chromosomal Abnormality

FDA places a clinical hold on Allogene Therapeutics clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in th...

Biologics

Pfizer Seeks Covid Vaccine EUA for Children 5-12

Pfizer and BioNTech say they have formally submitted an emergency use authorization request for their mRNA Covid-19 vaccine and its use in children ag...

Medical Devices

FDA Reclassifies Surgical Staplers, Staples

FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.

Human Drugs

De Novo Sought for Fibromyalgia Neuromodulator

NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults.

Human Drugs

Hospital, Health System Drug Compounding Guidance

FDA issues a revised draft guidance on drug compounding by hospital and health system pharmacies.

Polarean Imaging Complete Response Letter

FDA raises issues to be resolved in a complete response letter to a Polarean Imaging NDA for a drug-combination product to enhance MRI imaging in pulm...

Federal Register

Guide on Real-world Data for Animal Drug

Federal Register notice: FDA makes available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of...