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The state of Illinois is about to introduce a prescription drug importation program that goes far beyond anything any other state or municipality has so far attempted.
The Centers for Medicare & Medicaid Services announced that two more drugs have been added to the list of those covered under a Medicare replacement drug demonstration project.
Rep. Maurice Hinchey (D-N.Y.) said he doubts the claim by five former FDA chief counsels that a legal precedent has been established for unsolicited agency intervention on behalf of drugmakers in product liability suits.
The head of the FDA is asking the U.S. senator leading an investigation into the possible suppression of study results linking antidepressant use and pediatric suicide to delay interrogating agency employees until after the FDA has completely investigated the matter.
Generic firm Mylan Pharmaceuticals will seek an immediate appeal of a federal court ruling that prevents it from an early launch of a generic version of Johnson & Johnson’s pain-drug patch, Duragesic.
FDA’s decision on a widely watched follow-on biologics application should be delayed until after the agency holds a meeting next month on the scientific issues related to follow-on biologics and develops a draft guidance next year on how to approve versions of the complex proteins, according to Pfizer.
An agreement by two key senators on provisions to a bill that would require manufacturers to report serious adverse events (AEs) associated with dietary supplements and to conduct premarket testing of dietary stimulants is close, according to a spokesman for Sen. Richard Durbin (D-Ill.), a chief sponsor of the measure.
Scientific issues related to developing follow-on biologics and to examining what factors should be considered when assessing the similarities between a follow-on protein and the innovator product will be discussed at a two-day FDA meeting Sept. 14-15.