FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Advisors Reject Stronger Steroid Injection Warnings

[ Price : $8.95]

Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee recommend that FDA call for a targeted contraindicati...

FDA Clears Royal Phillips Iqon Spectral CT

[ Price : $8.95]

FDA clears a Royal Philips 510(k) for its IQon Spectral CT for use in computed tomography imaging.

Aurobindo Pharma Recalls One Lot of Gabapentin

[ Price : $8.95]

Aurobindo Pharma recalls one lot of generic gabapentin capsules (Pfizers Neurontin), USP 300 mg 100-count bottles due to the possi...

CDER Begins Posting Demographic Subgroup Data

[ Price : $8.95]

CDER begins posting demographic subgroup data for certain approved drugs.

New FDA Warning on Power Morcellators for Hysterectomies

[ Price : $8.95]

FDA issues an updated warning against using laparoscopic power morcellators to remove the uterus (hysterectomy) or fibroids (myome...

Rep. Bilirakis Introduces Orphan Drug Exclusivity Extension Bill

[ Price : $8.95]

U.S. Rep. Gus Bilirakis (R-FL) introduces H.R. 5750, the Orphan Product Extensions Now Accelerating Cures & Treatment Act, which w...

FDA Guidance on Design Considerations for Home-use Devices

[ Price : $8.95]

FDA posts a new guidance on Design Considerations for Devices Intended for Home Use that is intended to assist manufacturers in de...

Comments Sought on Clinical Trial Subgroup Posting

[ Price : $8.95]

Federal Register Notice: FDA requests comments on a new posting on the agencys Web site: Subgroup Data for FDA Approved Products, ...

FDA Denies Allergan Petition on Restasis Bioequivalence

[ Price : $8.95]

FDA denies an Allergan petition asking FDA to not accept or approve any ANDAs for its Restasis (cyclosporine ophthalmic emulsion) ...

FDA Orphan Designation for Duchenne Therapy

[ Price : $8.95]

FDA grants Catabasis Pharmaceuticals an orphan drug designation for CAT-1004 for treating Duchenne muscular dystrophy.