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Articles 1 - 12 of 12
Full-Text Articles in Law
The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards
The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards
Journal of the National Association of Administrative Law Judiciary
The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …
Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi
Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi
Journal of the National Association of Administrative Law Judiciary
This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …
Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs
Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs
Journal of the National Association of Administrative Law Judiciary
The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Christopher V. Smithkline Beecham Corporation: A Tough Pill To Swallow For Pharmaceutical Sales Representatives?, Hsuan Li
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco
Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs.
Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs.
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Book Reviews, David J. Agatstein
Book Reviews, David J. Agatstein
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner
Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein
Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen
California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen
Journal of the National Association of Administrative Law Judiciary
No abstract provided.