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Human Drugs

CorMedix Hit With 2nd Complete Response on DefenCath

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

Biologics

Objectionable Conditions at Valley Biosystems

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

Medical Devices

QS, MDR Violations at InfuTronix

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

Biologics

EUA for Modified Administration of Monkeypox Vaccine

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

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Marketing

Understanding Drug Risks and Benefits in Tweets

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

Human Drugs

Amazon Distributing Unapproved New Drugs: FDA

FDA warns Amazon.com that its fulfillment service is distributing unapproved new drugs sold over-the-counter as mole and skin tag removers.

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Human Drugs

FDA Extends Review of Reata Pharma NDA

FDA extends by three months the review of a Reata Pharmaceuticals NDA for omaveloxolone to allow time to evaluate additional data just submitted to th...

Federal Register

Allergenic Products Advisory Panel Renewed

Federal Register notice: FDA renews its Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date.

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Federal Register

50 NDAs Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that 50 listed drug products were not withdrawn for safety or effectiveness reasons.

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Human Drugs

Appeals Court Affirms Dismissal of FOIA Case

The 2nd Circuit Court of Appeals says a New York federal court properly granted summary judgment to FDA and Sarepta in a Freedom of Information Act ca...