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FDA Approval Letter for Mammography System

[ Price : $8.95]

FDA sends Carestream Health an approval letter for its CareStream DirectView CR, a high-resolution computed radiography system for...

FDA Reclassifies Full-Field Digital Mammography to Class 2

[ Price : $8.95]

Federal Register Final rule: FDA reclassifies the full-field digital mammography system from Class 3 to Class 2 with a guidance do...

Special Controls Guidance on Mammography Systems

[ Price : $8.95]

Federal Register Notice: FDA releases a special controls guidance on full-field digital mammography system.

MannKind Says Afrezza Whistleblower Suit Has No Merit

[ Price : $8.95]

MannKind says it will vigorously defend a suit charging that it fired a regulatory affairs senior manager in retaliation for his c...

Advisors Support Pozen Phase 3 Trial Design

[ Price : $8.95]

Pozen says a Gastrointestinal Drugs Advisory Committee vote supports its Phase 3 trial design for PA 32540 for secondary preventio...

Cellular Therapy Guidance

[ Price : $8.95]

FDA issues a guidance on trial information for sponsors of cellular therapy for cardiac disease.

FDA Approves BMS Diabetes Combo Drug

[ Price : $8.95]

FDA approves a Bristol-Myers Squibb NDA for Kombiglyze XR (saxagliptin and metformin extended-release) for treating Type 2 diabete...

FDA Not Considering Drug Model for Devices

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In its efforts to harmonize data standards for regulatory purposes, FDA principal deputy commissioner Joshua Sharfstein denies the...

FDA Wont Stay Approval of Pending Fentanyl Patch Applications

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FDA approves some elements of a Mylan petition on use of overlays with fentanyl patches.

CDER Compliance Expert Joins Parexel

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CDER Division of Manufacturing and Product Quality International Compliance Branch chief Edwin Rivera-Martinez retires from the ag...