FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Regulatory Review Period for Biogen Idecs Tecfidera

[ Price : $8.95]

Federal Register notice: FDA has determined the regulatory review period for patent restoration purposes for Biogen Idecs Tecfider...

Baxter Recalls Intralipid Lot Due to Subfreezing Storage

[ Price : $8.95]

Baxter International recalls one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, after it was exposed to sub...

Policy on Providing ANDA Review Status Updates to Sponsors

[ Price : $8.95]

CDER publishes a new Manual of Policies and Procedures (MAPP 5200.12) on Communicating Abbreviated New Drug Application Review Sta...

FDA Awards 15 Clinical Research Grants for Rare Diseases

[ Price : $8.95]

FDA awards 15 new clinical trial research grants totaling more than $22 million to advance product development for patients with r...

Gottlieb Says FDA Working Daily on Puerto Rico Manufacturing Capacity

[ Price : $8.95]

FDA continues working with Puerto Rico-based manufacturing facilities to restore their capacity in order to prevent possible medic...

FDA Spent PDUFA Fees Appropriately: OIG

[ Price : $8.95]

FDA has generally spent PDUFA user fee collections appropriately, according to an HHS Inspection General report.

FDA Clears Nexxt Spine 3-D Printing for Interbody/Vertebral Devices

[ Price : $8.95]

FDA clears a Nexxt Spine 510(k) for the Nexxt Matrixx System, 3-D printed porous titanium equipment for creating interbody and ver...

Noninferiority Trials Can Identify Innovations: Study

[ Price : $8.95]

Harvard Medical School researchers suggest ways to improve noninferiority clinical trials.

2017 CBER Recalls Up From 2016

[ Price : $8.95]

A FY 2017 CBER recall posting report details an 11% increase in total recalls over FY 2016.

ACLU Suit Challenges Mifeprex REMS

[ Price : $8.95]

The ACLU files suit against FDA REMS restrictions on access to the Mifeprex abortion pill.