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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...

Human Drugs

Acer Therapeutics NDA Resubmission Accepted

FDA accepts for review an Acer Therapeutics NDA resubmission for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea ...

Medical Devices

Covidien Recalls Palindrome and Mahurkar Catheters

Medtronics Covidien unit recalls (Class 1) its Palindrome and Mahurkar catheters due to a catheter hub defect that presents a potential leaking condit...

Human Drugs

FDA/Patent Office Coordination Bill Advances

A bill that would establish a task force between the U.S. Patent and Trademark Office and FDA to improve communication and coordination in implementin...

Medical Devices

FDA Oks Lenstec Segmented Bifocal Intraocular Lens

FDA approves a Lenstec PMA for its SBL-3 IOL (Segmented Bifocal Lens), a next-generation asymmetric multifocal refractive intraocular lens.