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Cantrell Drug Co. Recalls Products Due to Sterility

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

FDA Seeks Comments on 510(k) Submission Requirements

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

Comments Sought on Special Protocol Assessment Guidance Extension

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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

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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

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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

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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

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

Guide on MRI Premarket Notification Submissions

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Federal Register Notice: FDA announces the availability of a guidance entitled Submission of Premarket Notifications for Magnetic ...

Listing of Drugs Not Withdrawn for Safety/Effectiveness Reasons

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Federal Register notice: FDA determines that the drug products listed in this notice were not withdrawn from sale for reasons of s...

Draft Guide on Bladder Cancer Drug Development

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Federal Register Notice: FDA has made available a draft guidance on Bacillus Calmette-Guerin (BCG) Unresponsive Nonmuscle Invasiv...