FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on Multiplexed In Vitro Nucleic Acid Diagnostics

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid ...

Amarin Asks Specific Vascepa BE Testing

[ Price : $8.95]

Amarin petitions FDA to require specific bioequivalence testing for ANDA citing Vascepa as the reference-listed drug.

ISPE Announces Drug Shortage Prevention Plan

[ Price : $8.95]

The International Society for Pharmaceutical Engineering says it has a six-dimension plan to help avoid drug shortages.

Researchers Build an Open ADE Resource

[ Price : $8.95]

Researchers describe their effort to normalize data in the FDA Adverse Event Reporting System to make it more useful for data mini...

Celebrities in Drug Ads May Not be Influential

[ Price : $8.95]

Pharmafile says research shows that using celebrities in drug ads doesnt lead to consumer action to get a prescription.

Aegerion Resolves OPDP Warning Letter Citations

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion issues Aegerion Pharmaceuticals a close-out letter indicating the firms resolution of ...

FDA Issues Microbiological Countermeasures Guidance

[ Price : $8.95]

FDA publishes a guidance with recommendations for studies to establish the analytical and clinical performance of highly multiplex...

Court Upholds Ferring Lanham Case Dismissal

[ Price : $8.95]

The 3rd Circuit Appeals Court says a lower federal court correctly dismissed a Ferring petition for a preliminary injunction again...

Pfizer, Merck Join for Xalkor Trial

[ Price : $8.95]

Pfizer and Merck say they are collaborating in a Phase 1b trial of Pfizers Xalkor with Mercks pembrolizumab to treat patients with...

Panel to Discuss Watchman Cardiac Implant

[ Price : $8.95]

Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/8-9 to discuss a Boston Scientific PMA for its Watchma...