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Study Questions Some Accelerated Approval Uses

[ Price : $8.95]

Yale University researchers say giving sponsors extended periods to complete post-accelerated approval studies may not be justifie...

Research Uncovers Cyber Security Flaws in Device Software

[ Price : $8.95]

New research uncovers numerous software vulnerabilities in medical devices.

Electronic Submission of eSTAR 510(k)s Needed: Consultant

[ Price : $8.95]

Medical device regulatory consultant Adrienne Lenz says FDA needs to develop a way for medical device manufacturers to transmit el...

Arthrex Paying $16 Million to Resolve Kickback Case

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The Justice Department says Arthrex is paying $16 million to resolve a whistleblowers allegations of kickbacks leading to False Cl...

Product-specific Draft Bioquivalence Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-sp...

MedWatch Info Collection Extension

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Federal Register notice: FDA sends to OMB an information collection extension entitled MedWatch: The FDA Medical Products Reportin...

House Probes FDA/McKinsey Conflicts of Interest

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The House Oversight and Reform Committee requests information on FDAs consulting contracts with McKinsey due to potential conflict...

Animal Drug Regs Amended for Application Actions

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug and abb...

Woodcock Upbeat on Generic/Biosimilar Programs

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FDA acting commissioner Janet Woodcock says there continues to be huge opportunities for growth in the generic and biosimilar spac...

Eton/Azurity NDA Approved for Eprontia

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FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated a...