FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Adolor, GSK Respond to Entereg Approvable Letter

[ Price : $8.95]

FDA says it will act by 2/10/08 on an NDA for Adolor and GlaxoSmithKlines Entereg for managing postoperative ileus.

Latest FDA Warning Letters

[ Price : $8.95]

In todays batch of Warning Letters, FDA cites Spineology over an unapproved, misbranded, adulterated device, Optimesh.

Pennfield Oil NADA Withdrawn

[ Price : $8.95]

Federal Register Notice: FDA withdraws approval of a Pennfield Oil NADA for bacitracin zinc Type A medicated article because it is...

FDA Amends Regs on Pennfield Oil NADA

[ Price : $8.95]

Federal Register Final rule: FDA removes portions of the animal drug regulations that reflect approval of Pennfield Oils NADA for ...

New Pilot Between CDER and ORA to Enhance Inspections

[ Price : $8.95]

CDER and ORA plan a new pilot program beginning next fiscal year to share more key information from review divisions to help direc...

FDA Corrects Info on ICH Prep Meeting

[ Price : $8.95]

Federal Register Notice: FDA corrects the time for oral presentations for the Preparation for ICH meetings in Yokohama, Japan sche...

Quality Control Unit Cited Most During GMP Inspections

[ Price : $8.95]

FDA Office of Regulatory Affairs Division of Field Investigations director Michael Rogers tells an industry conference that the mo...

IDM Pharmas Mifamurtide Not Approvable

[ Price : $8.95]

FDA says IDM Pharmas mifamurtide is not approvable for treating non-metastatic osteosarcoma.

FDA Approves Medtronic Neck Disc

[ Price : $8.95]

FDA approves Medtronics Prestige Cervical Disc for use in the neck.

FDA Proposes OTC Sunscreen Monograph Change

[ Price : $8.95]

Federal Register Proposed rule: FDA proposes to amend the final monograph for over-the-counter sunscreen drug products to address ...