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Arizona Requires Registration of Contract Manufacturers

USA - March 1 2019 Like many states, Arizona requires that a non-resident manufacturer of prescription medical devices that sells or distributes its devices in Arizona...

Patricia F. Kaufman.

AdvaMed Proposes New Safe Harbors to the Anti-Kickback Statute for Value-Based Pricing Arrangements

USA - November 19 2018 AdvaMed, the trade association representing manufacturers of medical devices, diagnostic products, digital health Technologies and health information...

Alixandra Cossette.

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

USA - September 14 2017 In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New...

Patricia F. Kaufman.

FDA: The Powdered Gloves Come Off

USA - December 19 2016 In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they...

Patricia F. Kaufman, Ryan McGary.

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

USA - December 9 2016 On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and...

Patricia F. Kaufman, Ryan McGary.