Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Erin Bosman ordered by Published Date Descending.
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Committed To Clarity: FDA's Dedication To Transparency With The End Of ASR
On June 21, the Food and Drug Administration (FDA) released a report titled "Statement on agency's efforts to increase transparency in medical device reporting."
United States
15 Jul 2019
3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.
United States
17 Jan 2018
Expanding Duties And Eroding Protections For Medical Device Manufacturers
This decision comes as a surprise and represents an unexpected shift in the law with regard to medical device manufacturers.
United States
2 Mar 2017
FDA Releases Draft Guidance For Updating Generic Drug Labels
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels.
United States
25 Jul 2016
Regulating A Healthy Lifestyle? FDA Distributes New Draft Guidance On "General Wellness Products"
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products.
United States
4 Feb 2015
Generic Drug Manufacturers To Face Failure-To-Warn Claims In California
On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20, 2015).
United States
2 Feb 2015
"Generic" Logic Helps Branded Drug Achieve Dismissal
A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law.
United States
18 Nov 2014
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