FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Ultragenyx Plans Phase 2 Trial in Fatty Acid Oxidation Disorders

[ Price : $8.95]

Ultragenyx Pharmaceutical says an IND application for UX007, a treatment for long-chain fatty acid oxidation disorders is active a...

FDA Posts Final eCTD Specification Documents

[ Price : $8.95]

Federal Register Notice: FDA makes available on its Web site revised final versions of four documents that support making electron...

Info on ANADAs Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on ANADA applications to the Office of Management and Bu...

Comments Sought on New Dietary Ingredients

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on submitting information on dietary supplements or new dietary ingredients and a conc...

Guidance on BE Studies for Risperidone

[ Price : $8.95]

Federal Register Notice: FDA releases a revised draft guidance that provides specific recommendations for the design of bioequival...

FDA Delays ANDA Stability Recommendations Until 6/2014

[ Price : $8.95]

FDA delays until 6/2014 its implementation date for new recommendations in a recently released ANDA stability data guidance.

FDA Bioequivalence Guidance for Risperdal Generics

[ Price : $8.95]

FDA releases a bioequivalence guidance for generic copies of Janssens atypical antipsychotic Risperdal (risperidone).

Petition Filed After Product Liability Suit Fails

[ Price : $8.95]

A product liability plaintiff moves to the FDA citizen petition process to seek an investigation of adverse events and false adver...

Horizon, Par Settle Duexis Generic Duexis Availability

[ Price : $8.95]

Horizon Pharma enters into settlement and license agreements with Par Pharmaceutical to resolve pending patent litigation involvin...

FDA Withdraws 4 Quali-Tech NADAs

[ Price : $8.95]

Federal Register Final rule: FDA amends the animal drug regulations to reflect withdrawal of four Quali-Tech Products NADAs becaus...