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Concerns About Drug Shortage Draft Guidance

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Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.

Change Buprenorphine Labeling: Petition

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

More Philips Cybersecurity Feedback

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

Info Collection on Patent Restoration Petitions

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

FDA Updates Device Recognized Standards Listing

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

FDA Working on Januvia Shortage

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FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable i...

Comments on Radiolabeled Studies Draft

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Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.

FDA Clears ReShape Calibration Tubes

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

Califf Combats Misinformation with 'Rumor Control' Page

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

QS, Other Violations at Zyno Medical

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