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Human Drugs

Change Buprenorphine Labeling: Petition

The Colorado Society of Addiction Medicine says the labeling for buprenorphine products to treat opioid use disorder should be changed to recognize th...

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Medical Devices

More Philips Cybersecurity Feedback

Philips sends FDA additional comments on the agency discussion paper on strengthening cybersecurity practices for servicing medical devices.

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Federal Register

Info Collection on Patent Restoration Petitions

Federal Register notice: FDA seeks comments on an information collection extension entitled Patent Term Restoration; Due Diligence Petitions; Filing, ...

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Federal Register

FDA Updates Device Recognized Standards Listing

Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition List Number: 058....

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Human Drugs

FDA Working on Januvia Shortage

FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable intake levels to avoi...

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Human Drugs

Comments on Radiolabeled Studies Draft

Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.

Medical Devices

FDA Clears ReShape Calibration Tubes

FDA clears ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube in three sizes.

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FDA General

Califf Combats Misinformation with 'Rumor Control' Page

FDA and commissioner Robert Califf launch a new 'Rumor Control' Web page as part of the agency's first effort to address misinformation.

Medical Devices

QS, Other Violations at Zyno Medical

FDA warns Natick, MA-based Zyno Medical about Quality System and other violations in its production of infusion pumps and administration sets.

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Medical Devices

FDA Clears Bodyport Cardiac Fluid Scale

FDA clears a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status ...