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CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today…
…misprision of its duty. In Barr Laboratories, the court found that the contemplated order would have no effect on human health and welfare. Here, in contrast, compelling the FDA to…
…custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with Endotec, Inc., and the two individual defendants, Michael J. Pappas, Endotec’s co-owner and president, and…
…and issued a cease and desist order restraining POM’s future advertising. On March 8, 2013, POM filed a petition for review of the FTC’s Order in the D.C. Circuit. Surprisingly,…
…case. Earlier this week, the court allowed Zogenix’s motion for preliminary injunctive relief and enjoined, until April 22, 2014, the Commonwealth from taking any action to implement or enforce Governor…
…in Section 503A (i.e., exemptions from new drug, adequate directions for use, and cGMP requirements) were limited to compounding for individually identified patients pursuant to a prescription, but some in…
…stated that the agency has begun conducting scheduled inspections of retail and hospital pharmacies. Previously, DEA’s inspections of practitioners (doctors, pharmacies, etc.) was primarily limited to investigations into alleged violations….
…2021, unless DEA receives significant adverse comment. DEA will withdraw the rule by September 20, 2021, if it receives significant adverse comment. Electronic comments must be submitted, and written comments…
…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…
…as opposed to Active Pharmaceutical Ingredients) from Canada, by traveling to Canada and purchasing drugs in pharmacies there, or by mail order, either through Internet websites or through telephone purchases. …
…a set of principles and criteria. The NIH, which accepted the IOM report, charged a working group with, among other things, developing a plan of action to implement the guiding…
…the Dot Com Disclosures since May 2011. According to Mary Engle (Associate Director, FTC Division of Advertising Practices), the FTC is accepting written comments on the issue through July 11,…
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an associate with one to five years experience in food, dietary supplement, and OTC…
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an associate with three to five years experience in food, dietary supplement, and OTC…
As of the morning of March 1, the hotly anticipated Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee originally scheduled for…