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Guidance on Diagnostic Radiology Display 510(k) Submissions

[ Price : $8.95]

FDA releases a guidance on Display Devices for Diagnostic Radiology that is intended to assist industry in preparing premarket not...

Gottlieb Visits FDA Staff in Puerto Rico

[ Price : $8.95]

FDA commissioner Scott Gottlieb flies to Puerto Rico 9/29 to see firsthand the devastation caused by Hurricane Maria.

CDER Recognizes CDISC Clinical Data Standards Guide

[ Price : $8.95]

Federal Register notice: CDER announces support for version 1.1 of Clinical Data Interchange Standards Consortium, Analysis Data M...

Workshop on Complex Drug Equivalence

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Federal Register notice: FDA announces a 10/6 public workshop entitled Demonstrating Equivalence of Generic Complex Drug Substance...

FDA Reminds Device Makers of Cybersecurity Month

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FDA reminds medical device makers about the beginning of National Cybersecurity Awareness Month and to remain constantly vigilant ...

FDA Guide on Requesting Feedback on Device Submissions

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FDA makes available a guidance on Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings wit...

FDA Rejects Intellipharmaceutics Extended Release Opioid

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FDA issues Intellipharmaceutics International a complete response letter on its Rexista (oxycodone hydrochloride) extended-release...

Advisory Panel to Review Bayer Drug

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Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ci...

Guide on Advancing Emerging Technology In Drug Manufacturing

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Federal Register notice: FDA makes available a guidance entitled Advancement of Emerging Technology Applications for Pharmaceutica...

Guidance on Deficiencies in Device Submissions

[ Price : $8.95]

FDA makes available a guidance on Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.