Law Commons^™

When Rights Collide: In A Battle Between Pharmacists' Right Of Free Exercise And Patients' Right To Access Contraception, Who Wins?, Jacqueline Gilbert

Nevada Law Journal

No abstract provided.

Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann

Law Faculty Articles and Essays

Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.

The Hatch-Waxman Act And Market Exclusivity For Generic Manufacturers: An Entitlement Or An Incentive?, Ashlee B. Mehl

Chicago-Kent Law Review

One of Congress' central goals in enacting the Hatch-Waxman Act was to expedite and encourage earlier market entry for generic pharmaceutical products. The Act provides that a generic firm may challenge a drug patent during its term by filing paperwork with the FDA that alleges either that its generic product does not infringe the relevant patent, or that the patent is invalid. If the patentee disagrees with the allegation of the generic firm, it may file suit and have a court determine infringement and validity. If the generic firm prevails in court on either count, it may enter the market …

“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness

Law Faculty Scholarly Articles

Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, …

Fda, Clia, Or A "Reasonable Combination Of Both": Toward Increased Regulatory Oversight Of Genetic Testing, Douglas A. Grimm

University of San Francisco Law Review

This Article examines the current regulatory scheme for genetic testing and calls for a unification of the testing standards. It advocates consolidating the standards under a single governmental agency, FDA, in order to ameliorate the potential for immediate and future harm to patients and their families. In order to be effective, future regulations must apply to all providers of genetic testing and create meaningful, reasonable criteria for testing processes and outcomes.

How Does My Work Become Our Work? Dilution Of Authorship In Scientific Papers, And The Need For The Academy To Obey Copyright Law, Sean B. Seymore

Richmond Journal of Law & Technology

Professors enjoy a world of extensive institutional autonomy and individual academic freedom. Universities and courts defer to a professor’s judgment for “genuinely academic decisions” unless they depart from academic norms. Universities, courts, and professional societies should intervene, however, when academic norms and custom do not comport with the law.

Is Multidistrict Litigation A Just And Efficient Consolidation Technique? Using Diet Drug Litigation As A Model To Answer This Question, Danielle Oakley

Nevada Law Journal

No abstract provided.

The Health Act's Fda Defense To Punitive Damages: A Gift To Drug Makers Or To The Public?, Elissa Levy

Fordham Law Review

No abstract provided.

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …