FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Drug Supply Chain Security

[ Price : $8.95]

FDA issues a guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.

Getinge Recalls CardioHelp Emergency Drive

[ Price : $8.95]

Getinge recalls its CardioHelp Emergency Drive due to a possible blocking or impairment of its emergency crank.

FDA Withdraws Ciprofloxacin for Cystitis

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of Bayers Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five relate...

Info Collection on OTC Drugs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonpr...

Alpha Cognition NDA for Alzheimers Filed

[ Price : $8.95]

FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.

Positive Phase 1/2 Linvoseltamab Results to FDA

[ Price : $8.95]

Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 tri...

Pediatric Drug Development Bill Introduced

[ Price : $8.95]

Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.

Action Against BPI Methylene Blue Injection Asked

[ Price : $8.95]

Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.

Restrict ANDAs for Generic Xipere: Bausch & Lomb

[ Price : $8.95]

Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.

Guide on Drug Supply Verification Systems

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Verification Systems Under the Drug Supply Chain Security A...