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Research article

First published 2017-06

Trade Secret Protection on Technical Information in a Premarket Notification Submission for a Medical Device After TaiDoc Tech. Corp. v. OK Biotech Co.

Ping-Hsun Chen

Biotechnology Law Report

Free access

Research article

First published 1983-1

Comparative Requirements for Premarketing Premanufacture Notifications in the EC Countries and the USA,with Special Reference to Risk Assessment in the Framework of the US Toxic Substances Control Act (TSCA)

Joseph C. Arcos

International Journal of Toxicology

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Research article

First published 2013-9

Regulations of Medical Devices in Regulated Countries

G.V.S.S.N. Jyothi, M.P. Venkatesh, T.M. Pramod Kumar

Therapeutic Innovation & Regulatory Science

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Research article

First published 2002-12

Regulatory Aspects of Invasive Glucose Measurements

Steve Gutman, Patricia Bernhardt, Arleen Pinkos [...]

Diabetes Technology & Therapeutics

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Research article

First published 2002-11

Biotechnology at the Dinner Table: FDA's Oversight of Transgenic Food

Sheldon Krimsky, Nora K. Murphy

The ANNALS of the American Academy of Political and Social Science

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Review article

First published 2013-9

Regulatory perspectives on medical device approval in global jurisdictions

Deepak Kaushik, Shivaji Rai, Harish Dureja [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Open access

Review article

First published 2020-4

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019

Anais Rameau, Robert Stephen Hong, Hamid Djalilian [...]

OTO Open

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Research article

First published 2001-7

Food and Drug Administration Regulation of Orthotic Cranioplasty

Timothy R. Littlefield

The Cleft Palate Craniofacial Journal

Open access

Research article

First published 2018

Utility of generational developmental and reproductive toxicity and juvenile animal study protocols for the infant safety assessment of food contact materials

April Neal-Kluever, Queenster Nartey, Jason Aungst [...]

Toxicology Research and Application

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