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Medical Devices

Sidley Breaks Down Device Whistleblower Case Dismissal

Law firm Sidley draws attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to embrace the arguments...

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Human Drugs

Omeros Gets Orphan Status for PNH Therapy

FDA grants Omeros an orphan drug designation for OMS906 and its use in treating paroxysmal nocturnal hemoglobinuria (PNH).

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Federal Register

Regulatory Review Period for Accelerons Reblozyl

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Acceleron Pharmas Reblozyl (luspatercept-aamt)....

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Medical Devices

Siemens Healthineers Angiography System Cleared

FDA clears a Siemens Healthineers 510(k) for the ARTIS icono ceiling, a ceiling-mounted angiography system designed for routine and advanced procedure...

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FDA General

FTC Endorsement Guides Require Attention: Lawyer

Kleinfeld, Kaplan & Becker attorney Samantha Hong urges companies/marketers to evaluate and update their advertising and marketing practices to be in ...

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Federal Register

FDA Corrects Notice on ANDA Withdrawals

Federal Register notice: FDA corrects a notice that appeared in the 5/20 Federal Register announcing the approval withdrawals for 21 ANDAs involving m...

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Human Drugs

Califf Warns on User Fee Layoff Notices in September

FDA commissioner Robert Califf warns that FDA employees affected by user fee funds could start getting layoff notices in early September if House and ...

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Medical Devices

Some UV Wands are Unsafe: FDA

FDA warns consumers against using eight brands of ultraviolet wands for household disinfection due to the risk of unsafe radiation levels.

Human Drugs

3 Lessons Learned from Fosamax Failure-to-Warn Case

Attorney Daniel Feith describes three reasons why a recent New Jersey federal court decision helps manufacturers in failure-to-warn cases.

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Human Drugs

Micro-Organospheres Show Cancer Proof of Concept: NCI

The National Cancer Institute says researchers are expanding a study of micro-organospheres as a model to predict whether a cancer treatment will shri...