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5 Guidances Updating 510(k) Program

[ Price : $8.95]

FDA releases five guidances relating to expanding the 510(k) program that the Safety and Performance Based Pathway.

FDA Wants CNS Stimulant Abuse Deterrence Comments

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FDA solicits comments on abuse-deterrent formulations for prescription stimulants.

Info Collection Extension on MedSun Reporting

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for it MedSun adverse event program for medical...

Guide on Safer Technologies Device Program

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Federal Register notice: FDA posts a draft guidance entitled Safer Technologies Program for Medical Devices, a new, voluntary prog...

Final Guide on 505(q) Citizen Petitions

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Federal Register notice: FDA makes available a final guidance entitled Citizen Petitions and Petitions for Stay of Action Subject ...

FDA Updates RLD Access Inquiry List

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FDA updates its list of drugs for which the agency has received a reference-listed drug access inquiry.

Pelosi Releases Drug Pricing Bill

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House Speaker Nancy Pelosi releases her initial legislation to lower drug prices in ways she hopes will attract support from Presi...

Genentech Breakthrough Status for Lupus Nephritis Drug

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FDA grants Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis.

Meniscus Implant Gains Breakthrough Status

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FDA grants Active Implants a breakthrough device designation for the NUsurface Meniscus Implant.

FDA Clears Viseon Surgical Imaging Device

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FDA clears a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition im...