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Ease Off-label Speech Restrictions: WLF

Washington Legal Foundation urges FDA to ease its restrictions on manufacturer communications about off-label uses of FDA-approved drugs and medical d...

Medical Devices

FDA Video Explains Agency Role in 3D Printing

An FDA video discusses the agencys role in providing regulation, research, and resources for 3D printing.

Human Drugs

Complete Response Letters in 2016 Highest Since 2009

Retiring CDER Office of New Drugs director John Jenkins says that FDA issued 14 complete response letters in 2016, the highest number since 2009, whic...

Complete Response on Innocoll Combo Pain Product

FDA issues Innocoll a refuse-to-file letter for Xaracoll, the companys combination product candidate for treating postsurgical pain, because the submi...

Medical Devices

Nurse Assist Recalls Normal Saline Flush

Nurse Assist, Inc. begins a Class 1 recall of its Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill.

Federal Register

Tech Electronic Radiation Standards Committee Renewed

Federal Register notice: FDA renews its Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the chart...

Federal Register

Research Planned on Deceptive Drug Promotion

Federal Register Notice: FDA seeks comments on a new information collection related to Consumer and Healthcare Professional Identification of and Resp...

FDA General

OCI Director Resigns to Join Law Firm

FDA Office of Criminal Investigations director George Karavetsos resigns under fire and his last day is 1/20, the day president-elect Donald Trump is ...

Medical Devices

Medical Device Tax Repeal Introduced

Minnesota Republican congressman Erik Paulsen introduces a bill to repeal the medical device excise tax.

Human Drugs

Guidance on Medical Device Accessories

FDA posts a guidance on Medical Device Accessories Describing Accessories and Classification Pathway for New Accessory Types.