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Human Drugs

Chinese National Indicted Over Illegal Devices

An eastern California federal grand jury returns a three-count indictment against a citizen of China who formerly resided in Clovis, CA, charging him ...

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Federal Register

Complex Clinical Trial Design Workshop

Federal Register notice: FDA announces a public workshop entitled Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Pr...

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Federal Register

Meeting on Drugs for Preventing Preterm Birth

Federal Register notice: FDA announces a 1/23/24/2024 public meeting entitled Advancing Drug Development for the Prevention of Spontaneous Preterm Bir...

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Federal Register

Final Rule on DTC Ad Major Statement

Federal Register final rule: FDA posts a final rule on direct-to-consumer advertisements and a requirement that the major statement must be presented ...

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Medical Devices

GLP Report Translation Q&A Guidance

FDA publishes a draft guidance with questions and answers on translating GLP study reports into English.

Human Drugs

Concerns Over FDA Biosimilar Labeling Draft Guide

Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.

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Human Drugs

Repeat CGMP Violations at Cipla Plant

FDA warns Cipla about CGMP and other violations at its Madhya Pradesh, India-based drug manufacturing facility.

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Medical Devices

SoClean Recalls CPAP Device Cleaners

SoClean recalls its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and accessories.

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Study New Guide on Science Info for MDs: Attorneys

Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.

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Medical Devices

Medtronics Symplicity for Hypertension Approved

FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.