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Workshop on Complex Drug Equivalence

[ Price : $8.95]

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

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

Guide on Oncology Reproductive Toxicity Testing

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Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and...

Comments Sought on Opioid Policy Committee

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Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steer...

Aegerion Corporate Integrity Agreement Revealing: Attorneys

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A recent corporate integrity agreement between Aegerion Pharmaceuticals and HHS Office of Inspector General provides insights into...