FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Congress Should Legislate on Generic Label: Editor

[ Price : $8.95]

JAMA deputy editor Gregory Curfman calls for congressional action to resolve the question of who a consumer can sue when injured b...

FDA Clears 2 Techlab H. Pylori Tests

[ Price : $8.95]

FDA clears a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pyl...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that include Hangzhou Karic Commodities and Kyowa Hakko Bio.

UVision60 Luminelle DTx Hysteroscopy Cleared

[ Price : $8.95]

FDA clears a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures.

Audentes Therapeutics Regenerative Medicine Designation

[ Price : $8.95]

FDA grants Audentes Therapeutics a regenerative medicine advanced therapy designation for AT132 and its use in treating X-linked m...

Guide on Quality Attributes for Chewable Tablets

[ Price : $8.95]

FDA posts a guidance on Quality Attribute Considerations for Chewable Tablets that provides the agencys current thinking on the cr...

Guide Microdose Radiopharm Diagnostic Drugs

[ Price : $8.95]

FDA posts a guidance on Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.

Comments Extended on Animal Drug Trial Design Notice

[ Price : $8.95]

Federal Register notice: FDA extends the comment period for a previous notice about study designs intended to generate data to sup...

Info Collection Extension for Samples and Protocols

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Samples and Protocols.

Panel to Review Sequent Aneurysm Embolization Device

[ Price : $8.95]

Federal Register notice: FDA announces a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven End...