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Draft Guide on Diagnostic Ultrasound Systems and Transducers

[ Price : $8.95]

FDA makes available a draft guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

Two FDA Guidances on Advancing Complex Drug Generics

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FDA releases two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs.

FDA Guide on Requesting Rationales of Significant Decisions

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FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.

Guidance on Diagnostic Radiology Display 510(k) Submissions

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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

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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

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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...