FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

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.

GDUFA Completeness Assessment Guidance Out

[ Price : $8.95]

FDA issues a guidance explaining GDUFA requirements for holders of Type II API DMFs referenced in ANDAs, PSAs, or amendments to ei...

FTC Sets Drug Competition Workshop

[ Price : $8.95]

The Federal Trade Commission sets an 11/8 workshop on drug market competition with an address by FDA commissioner Scott Gottlieb.

Prior Approval Supplement Submission Guidance

[ Price : $8.95]

FDA issues a guidance on submitting to prior approval supplements and their amendments to FDA.

Public Meeting on Topical Dermatological ANDAs

[ Price : $8.95]

Federal Register: FDA announces a 10/20 public workshop on Topical Dermatological Generic Drug Products: Overcoming Barriers to De...

Common Technical Document Guidance Out

[ Price : $8.95]

FDA issues a guidance with recommendations for preparing the Common Technical Document for the Registration of Pharmaceuticals for...

FDA Worried About Sole-sourced Products from Puerto Rico: Gottlieb

[ Price : $8.95]

FDA commissioner Scott Gottlieb says the agency is very concerned about 13 sole-sourced drug products that are made in Puerto Rico...

Patient Engagement Advisory Committee Meeting Amendments

[ Price : $8.95]

Federal Register notice: FDA announces amendments to an earlier notice that provided details of a 10/11-12 Patient Engagement Advi...

Essure Postmarket Study Barely Off the Ground: Post

[ Price : $8.95]

ClassAction.com says an FDA-mandated postmarket surveillance study of Bayers Essure birth control device has enrolled only one pat...