FDA Related News

Human Drugs

CDER Expectations for CGMP, Data Integrity

Two CDER staffers present the Centers expectations for data integrity and CGMPs at a quality assurance meeting.

FDA General

Leininger Joins King & Spalding

Former FDA associate chief counsel for enforcement Peter Leininger joins King & Spalding.

Medical Devices

FDA Clears Clarify Light Therapy Device for Skin Diseases

FDA clears a Clarify Medical 510(k) for the Clarify Medical Phototherapy System, a light therapy device for treating diseases such as psoriasis, vitil...

Biologics

Amgen Files Repatha sBLA on CV Outcomes Data

Amgen files a supplemental BLA for Repatha (evolocumab), based on a cardiovascular outcomes study (FOURIER) which the company says showed that maximal...

Medical Devices

FDA OKs Inspires Next-gen Sleep Apnea Implant

FDA approves Inspire Medical Systems next generation Inspire 3028 implantable pulse generator for treating obstructive sleep apnea.

Groups Seek Block on Bills for Off-label Communications

Public Citizen and 12 other patient advocacy groups urge the House Energy and Commerce Committee members to reject two bills that would undermine regu...

Medical Devices

BMS/Qiagen Agreement on Immuno-oncology Products

Bristol-Myers Squibb and Qiagen enter into an agreement to explore using next-generation sequencing technology to develop gene expression profiles as ...

Medical Devices

FDA OKs Roche Test for Transplant Patient Monitoring

FDA approves a Roche PMA supplement for the cobas CMV (cytomegalovirus) test for use on its automated cobas 6800 and cobas 8800 Systems.

Human Drugs

CEL-SCI Responds to FDA Clinical Hold

CEL-SCI Corp. responds to FDA about a clinical hold placed on the companys Phase 3 head and neck cancer study with Multikine (leukocyte interleukin in...

Medical Devices

Claret Medical Clearance on Stroke Prevention Device

FDA allows the de novo marketing clearance of Claret Medicals Sentinel Cerebral Protection System to protect against the risk of stroke by capturing a...