FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Woodcock Discusses Collaborations to Advance Drug Development Science

[ Price : $8.95]

CDER director Janet Woodcock discusses collaborative efforts to advance regulatory science.

FDA Study Finds Reduce Risks for Pradaxa Compared to Warfarin

[ Price : $8.95]

An FDA study finds that Boehringer Ingelheim Pharmaceuticalss Pradaxa (dabigatran etexilate mesylate) was associated with reduced ...

FDA Partially Approves Petition on Proton Pump Safety

[ Price : $8.95]

FDA partially approves a 2011 Public Citizen petition calling on FDA to require labeling changes to all proton pump inhibitors.

Biosimilars Could Save U.S. $44 Billion: Analysis

[ Price : $8.95]

A new RAND Corp. analysis says that biosimilar products have the potential to cut spending on biologics in the U.S. by $44 billion...

Richard-Allan Scientific Class 1 Recall of Tissue Preservative

[ Price : $8.95]

Richard-Allan Scientific begins a Class 1 recall of its 10% Neutral Buffered Formalin due to product concentration concerns.

Astellas Granted Orphan Status for Antifungal

[ Price : $8.95]

FDA grants Astellas an orphan drug designation for isavuconazole and its use in treating invasive candidiasis.

FDA Accepts Boehringer NDA for Spiriva Respimat for Asthma

[ Price : $8.95]

FDA accepts for review a Boehringer Ingelheim NDA for Spiriva Respimat (tiotropium bromide) inhalation spray that is seeking an in...

FDA Nixes Data Fraud Rumors on Sarepta NDA Delay

[ Price : $8.95]

In an unprecedented move, FDA issues a statement to clarify that data integrity or fraud is not at the center of why Sarepta Thera...

OIG Work Plan Targets Five FDA Drug Program Areas

[ Price : $8.95]

The HHS Office of the Inspector General announces its Work Plan for fiscal year 2015 that targets five FDA drug program areas.

Lannett Gains Approval for Generic Femara

[ Price : $8.95]

FDA approves a Lannett Co. ANDA for letrozole tablets USP, 2.5 mg, a generic copy of Novartis Femara tablets.