…compendial guidelines to form the basis of criminal violations under the FDCA? Could the violation of a USP guideline or standard alone result in a criminal sanction? Does the non-delegation…

…Callanish in May 2010.  Callanish failed to appear after being served and the court entered Callanish’s default. Because of the default, the court accepted as true all well-pled facts in…

…included the “Preserve Access to Affordable Generics Act,” which is intended to curb patent settlement agreements (what opponents call “pay-for-delay” agreements).  The amendment appears to be identical to an amendment…

…less essential to an individual’s health care (i.e., those classified as health care operations) or all subsidized communications about products or services, including treatment communications.”  Thus, while paid switch communications…

…to suspend all approval and licenses as well as recall the preservative unless manufacturers could positively prove that it did not cause neurological damage in susceptible populations. The court first…

…“all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to [FDA] regarding the physical, chemical, and toxicological properties of…

…No. 111-238; pages 144-148 & 150-151) accompanying the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677).  The action follows testimony  given by Federal Trade Commission (“FTC”)…

…the Washington, D.C. Trial Department and co-head of National Recruiting. She has represented clients in federal, state, and administrative courts. Karla  is a 1992 graduate of the University of Richmond…

By Kurt R. Karst –    A recent analysis of the Congressional Budget Office’s (“CBO’s”) cost estimate of legislation intended to curb patent settlements (or what opponents call “pay-for-delay” or “reverse…

By Michelle L. Butler – Yesterday, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Special Advisory Bulletin regarding a new…

…that Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”), a subsidiary of Sun Pharmaceutical Industries Limited, submitted to the SEC raising an inquiry made to FDA about an interesting 180-day exclusivity forfeiture issue…

…five chemicals, JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol, are used to make “fake pot” products. These “smokable herbal blends” have been marketed as being legal substances, and have been increasing…

…FTC, direct purchasers, and indirect purchasers challenging certain agreements in which Solvay Pharmaceuticals, Inc. allegedly paid generic drug companies to delay generic competition to Solvay’s drug product ANDROGEL (testosterone gel). …

…civil money penalties. As swimmers in the social media pool, we also note with interest that CDER will (hopefully) address the promotion of prescription drug products using social media tools….

…and settlements, including cases involving pharmaceutical, medical device, and in vitro diagnostics companies.  She also has experience advising on matters involving other FDA enforcement activities, including for-cause inspections, warning letters,…