FDA and mutual recognition agreements: five models of harmonization.Nudging towards nutrition? Soft paternalism and obesity-related reform.Pandemic influenza: is there a corporate duty to prepare?FDA's regulation of tanning beds: how much heat?Data and market exclusivity for pharmaceuticals in the European Community.Authority of the Food and Drug Administration to require data access and control use rights in the Sentinel data network.Data quality and transparency in the dietary supplement industry.The World Health Organization's prequalification program and its potential effect on data exclusivity laws.Reverse-FOIA limitations on agency actions to disclose human gene therapy clinical trial data.Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.Current product equivalency issues.Are functional foods the solution to dysfunctional diets? A review of U.S. regulatory requirements and lessons from abroad.Xenotransplantation: ethics and economics.Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.Overview of the Hatch-Waxman Act and its impact on the drug development process.An alternative perspective: homeopathic drugs, Royal Copeland, and federal drug regulation.Saving U.S. dietary advice from conflicts of interest.Women's and fetal rights and interests: ethical aspects.The potential for self-interested behavior by pharmaceutical manufacturers through vertical integration with pharmacy benefit managers: the need for a new regulatory approach.Preemption and medical devices: a response to Adler and Mann.FDA regulatory review and approval processes: a Delphi inquiry.Implications of FDA's proposal to include foreign marketing experience in the over-the-counter drug review process.The regulation of foodstuffs with a specific health effect and health claims in Germany.The judicial coordination of drug and device litigation: a review and critique.Judicial review of FDA preemption determinations.Food industry initiatives to improve the FDA's food ingredient review processes.Teaching the elephant to dance: privatizing the FDA review process.FDA rulemaking after the 104th Congress: major rules enter the twilight zone of review.The evolution of substantial equivalence in FDA's premarket review of medical devices.One decade of food and drug law scholarship: a selected bibliography.Ethics of AIDS clinical trials in developing countries: a review.Pharmacy compounding of bioidentical hormone replacement therapy (BHRT): a proposed new approach to justify FDA regulation of these prescription drugs.Alternative dispute resolution in the advertising industry: the role of government regulation in the National Advertising Review Council ad review process.Advising under the influence?: conflicts of interest among FDA advisory committee members.Probiotics: achieving a better regulatory fit.Premarket notifications of new dietary ingredients--a ten-year review.The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing.FDA v. ephedra: is it time to lift the ban?Inconsistent government policies: why FDA off-label regulation cannot survive First Amendment review under Greater New Orleans.
P1433
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P1433
name
Food and Drug Law Journal
@de
type
label
Food and Drug Law Journal
@de
prefLabel
Food and Drug Law Journal
@de