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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
2
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
3
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
4
FDA Releases Draft Guidance For Updating Generic Drug Labels
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels.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
5
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 FDA Distributes New Draft Guidance On "General Wellness Products"
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products.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
6
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
7
"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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