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…interested parties cannot demonstrate the drugs’ safety, accelerate their compulsory withdrawal. Moving on to the schedule for compliance with the March 22nd Order, Magistrate Judge Francis ultimately adopted FDA’s proposed…
…from recent rulings by the District Court in similar challenges. See Order at 2, Prevor v. FDA, No. 11-1187 (D.D.C. May 8, 2013) (holding plaintiff’s motion to compel FDA to…
…the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce…
…“shall . . . issue an order withdrawing approval” language at FDC Act § 512(e)(1) comes into play – as follows: The principal question presented by this appeal is whether…
…this case three) really does spoil the bunch. As we previously reported here, in 2011, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen…
…regulation include: Apps that allow users to input their health information and through the application of formulas, data comparisons, or processing algorithms, issue a diagnosis or treatment recommendation that is…
…These terms have become increasingly important in the wake of FDA’s attempts to curtain how and what drugs may be compounded compounders may “Commercially Available” – FDA defines “commercially available”…
…under NDA 009053, which is currently held by Stason Pharmaceuticals. But the tablet dosage form raised issues for pediatric patients. According to Nova: Presently, a single 50mg strength tablet formulation…
…is a pharmacist, asked Secretary Burwell about office use compounding. Representative Carter expressed his concern about FDA’s interpretation of legislative intent dealing with “office use only” compounded medications. He addressed…
…the company, and criminal charges filed against three other former company employees, and a doctor who allegedly received kickbacks. Charging the president of a company is serious business, and if…
By Kurt R. Karst – Nothing lasts forever in our mortal world, though some things try to come close: Wonka’s Everlasting Gobstoppers, The NeverEnding Story, Doctor Who, the Energizer Bunny…
…of intent. See some of our prior posts, here, here, and here. If committed with an intent to defraud or mislead, an FDC Act violation can become a felony, which…
…address concerns about the increase in prescription drug abuse. The Plan is entitled: “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” Representing the Administration were White House Director of National…
…bar, one can likely rely on working Americans not returning to their doctor’s office after 48 hours for the serial test. The new regulation is listed as 21 CFR 866.3982:…
…outside of the clinic and without doctor supervision, it is virtually guaranteed that complex regulatory and public health questions will continue to arise. This is a fascinating subject, and we’ll…