Category Archives: Biologics

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FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs.  The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request … Continue Reading

FDA Issues Phthalate Draft Guidance For Pharmaceutical Products

In early March, the Food and Drug Administration (FDA) issued draft guidance recommending that the “pharmaceutical industry avoid the use of [dibutyl phthalate (DBP)] and [di(2-ethylhexyl) phthalate (DEHP)] in [Center for Drug Evaluation and Research (CDER)]-regulated drug and biologic products,” including prescription and nonprescription products, because of “potential human health risks associated with exposure to … Continue Reading

U.S. Supreme Court Upholds Federal Preemption In Childhood Vaccine Liability Case

Late last month, the U.S. Supreme Court ruled on a significant federal preemption case concerning an individual’s right to sue a vaccine manufacturer for injury that is alleged to have resulted from a defect in a vaccine’s design. The 6-2 decision (Justice Kagan recused herself) in Bruesewitz v. Wyeth held that a provision within the … Continue Reading