FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

More Time Needed for cGMP Combination Product Rule: Genentech

[ Price : $8.95]

Genentech tells FDA that small entities will need considerably more than the 25 hours per product FDA has estimated for assuring c...

FDA Approves Intelence

[ Price : $8.95]

FDA gives traditional approval to Tibotecs Intelence for treating HIV-1 infection in certain patients.

Novartis Wins Liability Suit with Preemption Defense

[ Price : $8.95]

A federal appeals court dismisses a product liability suit against Novartis after the drug maker successfully argues for preemptio...

FDA Cancels Panel Review of Tykerb sNDA

[ Price : $8.95]

FDA says it has canceled a planned 12/16 advisory committee review of a GlaxoSmithKline supplemental NDA for Tykerb (lapatinib) ta...

FDA Accepts NDA for Aricept ER Formulation

[ Price : $8.95]

FDA accepts for review an Eisai NDA for once-daily 23 mg Aricept (donepezil HCl) extended-release tablets for treating moderate to...

Zalbin BLA Submitted

[ Price : $8.95]

Human Genome Sciences submits a BLA to FDA for Zalbin to treat hepatitis C.

FDA Clears Prodesse ProParaflu Assay

[ Price : $8.95]

FDA clears a Prodesse 510(k) for the ProParaflu+ assay, a molecular test used to detects and differentiate parainfluenza 1, 2 and ...

Animal Drug Sponsor Changed to Schering-Plough

[ Price : $8.95]

Federal Register Final rule: FDA amends the animal drug regulations to reflect a change of sponsor for 29 NADAs for 2 ANADAs to Sc...

IT Advances Not Speeding Drug Approvals: Study

[ Price : $8.95]

East Carolina University researchers say that FDAs new information technology systems has not cut the time needed to review NDAs.

FDA Clarifies Labeling Requirements for OTC Pain Drugs

[ Price : $8.95]

Federal Register Final rule: FDA amends a final rule on labeling for OTC internal analgesic, antipyretic, and antirheumatic drug p...