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Guide on OTC Aspirin Labels Using Heart Imagery

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FDA posts a guidance on Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Re...

FDA Guidance on Hep C Drug Development

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FDA releases a guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.

Guide on Scientific Dispute Resolution

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Federal Register notice: FDA makes available a guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level.

Draft Guide on ANDA Pre-submission Facility Info

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Federal Register notice: FDA makesavailable a revised draft guidance entitled ANDAs: Pre-Submission of Facility Information Relate...

FDA Offers Flexible Approach for Genetic Health Risk Tests

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FDA seeks to implement a novel regulatory approach for direct-to-consumer genetic health risk tests that will use flexible oversig...

Defense Bill Language Could Usurp FDA Emergency Approvals

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Legislative language in an FY 2018 Defense Department spending bill gives the military the authority to approve the emergency use ...

Comments Sought on Supplement Claims Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension provision under its Guidance for Industry: Subs...

Listing of Recent Information Collections Approved by OMB

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Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and B...

FDA Reverses More-Data Request on Vaginal Pain Drug

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In a move that may signal the agencys increasing reliance on real world data, FDA reverses its decision to require TherapeuticsMD ...

Device Compliance Head Newman Leaves FDA

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CDRH Office of Compliance director Robin Newman leaves the agency to pursue an undisclosed opportunity.