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FDA Clears ReShape Calibration Tubes

[ Price : $8.95]

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

Califf Combats Misinformation with 'Rumor Control' Page

[ Price : $8.95]

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

Concerns About Drug Shortage Draft Guidance

[ Price : $8.95]

Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.

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

[ Price : $8.95]

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

Info Collection on Patent Restoration Petitions

[ Price : $8.95]

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

QS, Other Violations at Zyno Medical

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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.