FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Clinical Trial Violations at Endogastric Solutions

[ Price : $8.95]

FDA warns Endogastric Solutions about violations in its conduct of a clinical trial for a weight loss device.

FDA Awards $40 Million Contract for Employee Communications

[ Price : $8.95]

FDA awards a five-year $40 million contract to Reston, VA-based Discover Technologies to help the agency improve its internal comm...

QS Violations Found at Arriol International

[ Price : $8.95]

FDA warns Arriol Internation about Quality System violations in manufacturing its EZ IO intra osseous injection system and aseptic...

Solicitor General Asked for Comment on Classen Case

[ Price : $8.95]

Attorney Christine Norris says the Supreme Court may hear appeals from a lower court decision in Momenta v. Amphastar after hearin...

Comments Sought on Influenza Reagent Guidance

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a guidance on reagents for detecting specific novel influenza A viruses.

Info on Clinical Investigations Oversight Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a collection of information on a draft guidance on a risk-based approach to the oversight of ...

Guidance on ANDA Stability Testing

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on stability testing of drug substances and products for ANDAs.

Guidance on Pre-Storage Leukocyte Reduction of Blood/Components

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on pre-storage leukocyte reduction of whole blood and blood components intended f...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Aino Co., Ltd. of North China Pharmaceutical Group, Arriol International, Atlant...

Astellas NDA for Tacrolimus ER for Kidney/Liver Transplants

[ Price : $8.95]

Astellas Pharma files an NDA for tacrolimus extended release capsules for preventing organ rejection in adult kidney and liver tra...