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FDA Mulls Allowing Links to Risk Info in Social Media Messaging

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FDA considers industry and advertiser proposals to allow links to risk information for promotional activities on character space-l...

Comments Sought on Extending Use of Focus Groups

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Federal Register Notice: FDA asks for comments on an OMB submission seeking an information collection extension on the use of focu...

FDA Docket Established on Patient Partnerships

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Federal Register Notice: FDA establishes a public docket to receive input on a CDRH new program on Patient and Care-partner Connec...

Guidance on IDEs for Neurological Devices

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Federal Register Notice: FDA makes available a guidance on Clinical Considerations for Investigational Device Exemptions (IDEs) fo...

FDA Delays Review Action on BioMarin NDA

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FDA tells BioMarin that it has not yet completed the review process for its NDA on Kyndrisa (drisapersen) and it will not take an ...

FDA Approves Fecal Continence Device

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FDA approves a Torax Medical humanitarian device exemption for the Fenix Continence Restoration System to treat fecal incontinence...

FDA Clears GI Logic AbStats System

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FDA clears a GI Logic 510(k) for the AbStats System to be used by physicians in hospitals and other healthcare settings for real t...

Congress Suspends Medical Device Tax

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Congress approves a budget and tax deal that will suspend the 2.3% medical device excise tax that has been in effect since 1/2013.

Industry Seeks More Clarity on Flexible Regulatory Approaches

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Pharmaceutical Research and Manufacturers of America and Pfizer comment on a draft guidance on Rare Diseases: Common Issues in Dru...

FDA Clears Luminex Respiratory Pathogen Assay

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FDA clears a Luminex 510(k) for its NxTAG Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respi...