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FTC Commissioner Makes Case Against Pay-for-Delay

[ Price : $8.95]

FTC commissioner Julie Brill makes the case for working to overturn anti-competitive pay-for-delay settlements.

Many Changes Sought in Cyber Security Guidance

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Stakeholders call on FDA to make significant changes to a draft cyber security guidance document for medical devices.

Oversight Board Discusses Medical Product Safety

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The FDA Drug Safety Oversight Board discusses medical product safety objectives being sought by the agency through its work with H...

Shamrock Medical Solutions Group Consent Decree Approved

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An Ohio federal judge approves a permanent injunction sought by FDA against Shamrock Medical Solutions Group for drug GMP and labe...

FDA Accepts AstraZeneca NDA for High Triglycerides

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FDA accepts for review an NDA from AstraZeneca subsidiary Omthera Pharmaceuticals for the investigational drug Epanova to treat se...

Guidance on Patient Counseling Section for Drug/Biologic Labels

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Federal Register Notice: FDA releases a draft guidance: Patient Counseling Information Section of Labeling for Human Prescription ...

Guidance on Electronic Source Data in Clinical Trials

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Federal Register Notice: FDA releases a guidance: Electronic Source Data in Clinical Investigations.

FDA Needs Good Reason to Detain Drugs: Comment

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Novo Nordisk and BIO ask FDA to spell out a drug detention policy that doesnt keep safe medicines from people who need them.

FDA Warns Against Weight Loss Product

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FDA advises consumers to refrain from purchasing and throw away any bottles of the weight loss product Shou Fu Ti Tun Guo Xiang Xi...

Electronic Source Data Guidance

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FDA publishes a guidance with recommendations for capturing, reviewing, and retaining electronic source data in clinical investiga...