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FDA Offers Flexible Approach for Genetic Health Risk Tests

[ Price : $8.95]

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.

Medacta 3DMetal Tibial Cone for Knee Revision Cleared

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FDA clears a Medacta International 510(k) for its 3DMetal Tibial Cones for knee revision surgery.

Draft Guide on ANDA Pre-submission of Facility Information

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FDA posts a revised draft guidance on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applicatio...

REMS Could Include Healthcare Provider Continuing Education: FDA

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FDA concludes that healthcare provider continuing education can be a useful method for providing continuing education under a risk...

Draft Guide on Controlled Correspondence for Generics

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Federal Register notice: FDA makes available a draft guidance on Controlled Correspondence Related to Generic Drug Development.