FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CVM Report on Combination NADAs with Medicated Feeds

[ Price : $8.95]

Federal Register Notice: FDA makes available a report on a CVM working group that proposes possible changes to the current review ...

Guide on Generic Drug User Fee Questions & Answers

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Generic Drug User Fee Amendments of 2012: Questions and Answers R...

FDA Officials Seek Improvements in Device Feasibility Studies

[ Price : $8.95]

FDA officials suggest approaches to improving medical device early feasibility studies in the U.S.

Cantrell Drug Co. Recalls Products Due to Sterility

[ Price : $8.95]

Cantrell Drug Co. recalls certain unexpired sterile drug products due to lack of sterility assurance.

FDA Seeks Comments on 510(k) Submission Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection extension on medical device premarket notifications.

Comments Sought on Special Protocol Assessment Guidance Extension

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection extension on its Guidance for Industry on Special Protoco...

Final Rule on Medical Gas GMPs

[ Price : $8.95]

Federal Register Final Rule: FDA amends its current good manufacturing practice and labeling regulations regarding medical gases t...

FDA Delays Guidelines on Regulating Lab-developed Tests

[ Price : $8.95]

FDA says it is delaying guidelines for regulating laboratory-developed tests until after the Trump administration takes office in ...

CDRH and Groups Pen Agreement on Device Cybersecurity

[ Price : $8.95]

CDRH, The National Health Information Sharing and Analysis Center, and the Medical Device Innovation, Safety and Security Consorti...

Apricus Bio Plans Vitaros NDA Resubmission in 2017

[ Price : $8.95]

Apricus Biosciences says it has received FDA feedback that supported the companys strategy for addressing deficiencies contained i...