FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments Sought on Info Collection for Expedited Product Programs

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision for its Guidance for Industry on Expedited Progr...

Adverse Reports from United Pharmacy Injectable

[ Price : $8.95]

FDA says it has investigated two adverse event results from a United Pharmacy compounded glutamine, arginine, and carnitine produc...

FDA OKs Expanded Abuse Deterrent Claims for Xtampza

[ Price : $8.95]

FDA approves a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abus...

Courts Should Defer to FDA Pediatric Policy: Professor

[ Price : $8.95]

A Yale Law School professor says court should back FDAs denial of pediatric exclusivity for Amgens Sensipar because one of the com...

Roche Ventana ALK Assay Approved by FDA

[ Price : $8.95]

FDA approves a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase-pos...

Objectionable Conditions Found at Dentists Clinical Site

[ Price : $8.95]

FDA warns California dentist William Domb about violations in his conduct of a clinical study using ozone generators.

Potential Pay-for-Delay Settlements Down: Report

[ Price : $8.95]

A Federal Trade Commission report says that the number of potential pay-for-delay patent dispute settlements in FY 2015 was signif...

CGMP Violations at Guangdong Zhanjiang Jimin

[ Price : $8.95]

FDA warns Chinas Guangdong Zhanjiang Jimin Pharmaceutical Co. about CGMP and other violations in its production of finished pharma...

False Claims Act Off-Label Promotion Case Fails

[ Price : $8.95]

Sixth Circuit Appeals Court decision upholds dismissal of a False Claims Act whistleblower case against Bristol-Myers Squibb based...

Class 2 for Health Risk Assessment Systems

[ Price : $8.95]

Federal Register notice: FDA classifies genetic health risk assessment systems into Class 2 (special controls).