Medical Drug Device Law Blog

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Drug & Device Law | Prescription Medical Products …

https://www.druganddevicelawblog.com/

By Bexis on February 10, 2023. Today’s guest post by Reed Smith’s Kevin Hara arises indirectly from the Zantac MDL, but addresses a recurring preliminary question of federal …

The Thrill of Victory - The Ten Best Prescription Drug/Medical …

https://www.druganddevicelawblog.com/2022/12/the-thrill-of-victory-the-ten-best-prescription-drug-medical-device-decisions-of-2022.html

Dearinger v. Eli Lilly & Co., 510 P.3d 326 (Wash. 2022). Our best case of 2022, and our only …

FDA Law Blog

https://www.thefdalawblog.com/

FDA declared 2016 the “Year of Clinical Trials Diversity” and that year, issued two guidance documents, one for drug and one for device studies, to standardize …

Medical Devices | FDA Law Blog

https://www.thefdalawblog.com/category/medical-devices/

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. …

Topics | Drug & Device Law | Prescription …

https://www.druganddevicelawblog.com/topics

Drug & Device Resources Bexis’ Book FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the …

Logical Contradiction Doctrine: Buckman for Textualists | Drug

https://www.druganddevicelawblog.com/2023/01/logical-contradiction-doctrine-buckman-for-textualists.html

A final FDA action, such as the approval of a drug or device – including its warnings – is “law” under Justice Thomas’ reading of the Supremacy Clause. Thus a …

Under FDORA, FDA to Require Most Drug and Device Trials to …

https://www.thefdalawblog.com/2023/01/under-fdora-fda-to-require-most-drug-and-device-trials-to-submit-diversity-action-plans/

FDA declared 2016 the “Year of Clinical Trials Diversity” and that year, issued two guidance documents, one for drug and one for device studies, to standardize …

A Primer on Alternative Design | Drug & Device Law

https://www.druganddevicelawblog.com/2023/02/a-primer-on-alternative-design.html

A Primer on Alternative Design. By Bexis on February 16, 2023. Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible …

Bexis | Drug & Device Law Prescription Medical …

https://www.druganddevicelawblog.com/author/jbeck

He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off …

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