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Human Drugs

iTeos Regains Rights from Pfizer for Oncology Therapy

iTeos Therapeutics regains exclusive worldwide rights from Pfizer to develop EOS200271, a highly selective, clinical-stage indoleamine 2,3-dioxygenase...

Federal Register

Cervical Intraepithelial Neoplasia Tests Put Into Class 2

Federal Register notice: FDA classifies the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls).

Medical Devices

FDA Clears Cerebrotech Visor Fluid Monitor

FDA clears a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor.

FDA General

Praise for Gottlieb Amid FDA Successes in 2017

A Health Affairs article heaps praise on FDA commissioner Scott Gottlieb in a review of agency accomplishments last year.

Human Drugs

FDA Clears Cerebrotech Visor Fluid Monitor

FDA clears a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor.

Federal Register

Draft Guide on Certain Contraceptive Labeling

Federal Register notice: FDA makes available a draft guidance on Labeling for Combined Hormonal Contraceptives.

Federal Register

Pediatric Advisory Committee Meeting in March

Federal Register notice: FDA announces a 3/23 Pediatric Advisory Committee meeting.

FDA General

Groups Oppose Azar HHS Nomination

Some 60 stakeholder groups air their opposition to the nomination of former Lilly executive Alex Azar to be HHS secretary.

Federal Register

Draft Guide on Hypogonadotropic Hypogonadism Drugs

Federal Register notice: FDA makes available a draft guidance entitled Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hy...

Medical Devices

FDA Clears Zimmer Biomet Shoulder System

FDA clears a Zimmer Biomet Holdings 510(k) for the Sidus Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bo...