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Medical Devices

FDA Alert on ENFit Low Dose Tip Syringes

FDA issues a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip syringes.

Medical Devices

FAQ on Sodium Citrate Blood Specimen Collection Tubes

FDA issues an online Frequently Asked Questions document on the shortage of sodium citrate blood specimen collection tubes used in coagulation testing...

Medical Devices

Life Spine ProLift Expandable Spacer Cleared

FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar interbody fusion proc...

Human Drugs

Contract Testing Lab Hit with Warning Letter

FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significant GMP violations fo...

Federal Register

Panel to Review Pfizer Covid Vaccine in Kids

Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and discuss Pfizer-BioNTe...

Human Drugs

FDA Changing Isotretinoin iPLEDGE REMS Requirements

FDA approves changes to the isotretinoin iPLEDGE REMS.

Medical Devices

Quanterix Gets Breakthrough for Alzheimers Test

FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers Disease.

Human Drugs

Protagonist Therapeutics Hold Lifted on Trials

FDA removes a Protagonist Therapeutics clinical hold on the company's rusfertide clinical tumor-detection studies.

Human Drugs

FDA Broadens Dextenza to Include Ocular Itching

FDA approves an Ocular Therapeutix supplemental NDA to broaden Dextenzas (dexamethasone ophthalmic insert) label to add an additional indication for t...

Biologics

Enzyvant Therapeutics Athymia Tissue-based Product OKd

FDA approves Enzyvant Therapeutics thymus tissue-based product Rethymic for treating pediatric patients with congenital athymia, a rare immune disorde...