FDA Related News

Senate and House Leaders Eager to Push Cures Act Through

Senate and House leaders signal strong interest in seeing the 21st Century Cures Act signed into law this year.

Federal Register

Comments Sought on Radiation Product Requirements

Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on reporting and recordkeeping requirements for m...

Federal Register

Draft Guide on Surgical Aspirator Device Labeling

Federal Register Notice: FDA makes available a draft guidance on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.

Human Drugs

Partial Clinical Hold Lifted on Adaptimmune T-cell Therapy

FDA removes a partial clinical hold on a Adaptimmune Therapeutics planned study of its NY‑ESO SPEAR (Specific Peptide Enhanced Affinity Receptor...

Human Drugs

Multiple Violations at Cantrell Drug Company

FDA publishes an FDA-483 with 12 inspection observations from Cantrell Drug Co., an outsourcing facility.

Medical Devices

FDA Starts Neurological Device Web Site

FDA launches a new Web site to help sponsors and innovators of neurological medical devices.

Human Drugs

FDA OKs Opdivo for Head/Neck Carcinoma

FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck....

Medical Devices

Group Wants FDA Warning on Dental Amalgam

Consumers for Dental Choice asks FDA to take three steps to warn dentists, parents, and dental consumers against amalgam use in children, pregnant wom...

21st Century Cures May Be on Fast Track

Political analysts see the possibility for compromise 21st Century Cures legislation to be approved by the lame duck Congress that returns to Washingt...

Human Drugs

Inspector General EpiPen Records Sought

Sen. Chuck Grassley asks the HHS inspector general for records relating its 2009 determination that the EpiPen had been misclassified and taxpayers we...