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Medical Devices

Warning on Needle-free Devices for Dermal Fillers

FDA issues a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and...

Federal Register

Panel to Discuss Moderna, Janssen Vaccine Boosters

Federal Register notice: FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting.

Federal Register

Revised Guide on Hospital Drug Compounding

Federal Register notice: FDA releases a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food,...

Medical Devices

Imperative Care Zoom Catheter Recall is Class 1

FDA says the Imperative Care recall of specific lots of its ZOOM 71 reperfusion catheter is Class 1.

Federal Register

Info Collection Revision on Device Labeling

Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Regulations.

Human Drugs

FDA Recognizes Molecular Tumor Marker Database

FDA recognizes a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base.

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...