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Medical Devices

Warning on Apyx Medicals Renuvion Device

FDA warns against using Apyx Medicals Renuvion/J-Plasma device for certain aesthetic procedures, such as those intended to improve the appearance of t...

Human Drugs

Lynparza Approved for Certain Early Breast Cancer

FDA approves AstraZenecas Lynparza (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mut...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/11/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 3/11/2022.

Medical Devices

Philips Hit With Rare 518(a) Order on Ventilators

After determining inadequate recall notifications to date, FDA issues a rare Section 518(a) notification order to Philips Respironics requiring the co...

Human Drugs

Hold Lifted on Immunome Covid Antibody Cocktail

FDA removes an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19 after the company provided more therapy preparation ...

FDA General

Ex-Blackstone Sales Director Gets 51 Months Sentence

A federal judge sentences James Boccuzzi of Parkland, FL, a former sales director for Blackstone Labs, to 51 months in prison for conspiring to defrau...

Federal Register

Class 2 for Automated Glycemic Controllers

Federal Register notice: FDA classifies the interoperable automated glycemic controller into medical device Class 2 (special controls).

Human Drugs

FDA Releases 5-page Form 483 to Leesar Inc.

FDA releases a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility.