FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts Ariad NDA for Lung Cancer

[ Price : $8.95]

FDA accepts for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase inhibitor f...

Appeals Court Asked to Overturn Flonase Case Ruling

[ Price : $8.95]

Washington Legal Foundation and the National Association of Manufacturers ask the 3rd Circuit Appeals Court to reject a Pennsylvan...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Beijing Taiyang Pharmaceutical Industry, Option Care Enterprises, and Wellcare R...

FDA Priority Review for Novartis Breast Cancer Drug

[ Price : $8.95]

FDA accepts for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with horm...

Beijing Taiyang Refused, Limited FDA Inspection

[ Price : $8.95]

FDA warns Chinas Beijing Taiyang Pharmaceutical Co. about limiting and refusing an agency inspection and CGMP deviations.

Comments Extended on GLP Proposed Rule

[ Price : $8.95]

Federal Register Proposed Rule comment extension: FDA extends the comment period for an 8/24 proposed rule to amend the regulation...

Guide on Female Sterilization Implant Labeling

[ Price : $8.95]

Federal Register Notice. FDA makes available a guidance on Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended...

Only 58% of Drug Postmarketing Requirements Filed on Time

[ Price : $8.95]

The latest FDA report on the status of postmarketing requirements and commitments shows that drug and biologic companies submit an...

Attorneys Weigh FDA Reporting of Cybersecurity Upgrades

[ Price : $8.95]

A client alert by DLA Piper attorneys reviews when a cybersecurity-related change to a device is reportable to FDA.

FDA Allows Marketing of Becton Dickinson Vaginitis Assay

[ Price : $8.95]

FDA approves a de novo petition to allow marketing of a Becton Dickinson molecular test to detect the most common causes of vagini...