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Change Buprenorphine Labeling: Petition

[ Price : $8.95]

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...

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...

FDA Clears Bodyport Cardiac Fluid Scale

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

CorMedix Hit With 2nd Complete Response on DefenCath

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FDA sends CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use...

Objectionable Conditions at Valley Biosystems

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FDA warns West Sacramento, CA-based Valley Biosystems about violations in its conduct of two nonclinical laboratory studies.

QS, MDR Violations at InfuTronix

[ Price : $8.95]

FDA warns Natick, MA-based Infutronix about Quality System and Medical Device Reporting violations in its production of infusion p...

EUA for Modified Administration of Monkeypox Vaccine

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FDA issues Bavarian Nordic an emergency use authorization for its smallpox/monkeypox vaccine Jynneos to allow healthcare providers...

Understanding Drug Risks and Benefits in Tweets

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CDER advertising researchers say their study of character-space-limited communications like Tweets in terms of drug benefit and ri...