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Medical Devices

Violations in Uscom Spirometer Inspection

FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its facility in Budapest,...

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Human Drugs

Hikma Injectables FDA-483 Out

FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing facility.

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Human Drugs

Researchers Affirm Mifepristone Safety to FDA

More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety and effectiveness in ...

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Human Drugs

FDA Looking at MASH Surrogate

FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a surro...

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Human Drugs

Grace Therapeutics NDA for Hemorrhage Drug Submitted

FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage.

Biologics

Limited Covid Vaccines OKd for Upcoming Season

FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of SARS-CoV-2; the age...

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Medical Devices

11 QS, MDR Violations at Miach Orthopaedics

FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its production of the B...

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Human Drugs

BIO September Congressional Priorities

The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA pediatric priority r...

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Human Drugs

Multiple GLP Violations at Chinas Jiangsu Kerbio

FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical studies.

Medical Devices

FDA Breakthrough Status for Lupis Blood Purifier

FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant s...