By Riëtte van Laack – Approximately three years ago, the Federal Trade Commission (“FTC”) filed a complaint against Daniel Chapter One and James Fijio (“DCO”) for the advertising of four…

…certain health care providers.  FDA has not yet substantively responded to that petition either.)  Although the legal wrangling between Lannett and Celgene over a settlement of the case has delayed…

…2. Although the Act does allow manufacturers to avoid the tax penalty by terminating its agreements for all of its drugs under Medicaid and Medicare (i.e., the Medicaid Drug Rebate…

…it “will allow all report submissions to be received more quickly and stored in a central database, as well as allow for analysis.” Id. at 40710. Step 1: Initial Notification…

…and is not illegal off-label practices, rather than publishing regulations to spell out exactly what companies can and cannot do. Few defendants have gone to trial in off-label cases, and…

…a 30-month stay on FDA’s approval of a generic drug application.  (The most recent case we can think of is from 2009, when the U.S. Court of Appeals for the…

…the pharmacological effects of synthetic cathinones are similar to those of highly abused products such as methamphetamine, cathinone, methcathinone and MDMA. They cause, among other effects, agitation, tachycardia, dilated pupils,…

…Cosmetic Act as well as the Public Health Service Act.  Complaint at 12.  Regenerative contends that the manipulation of stem cells occurs in the normal course of a medical practice…

…presentations in patient-care areas.  In addition, all educational programs and materials would have to be approved by the facility in advance of the program, and no promotional activities would be…

By Anne K. Walsh – On November 2, 2011, DOJ’s Assistant Attorney General Tony West gave a keynote address at the Twelfth Annual Pharmaceutical Regulatory and Compliance Congress in Washington,…

…et. al. requesting that the California Supreme Court review the appeals court decision. The California Supreme Court does not automatically review appeals court decisions in civil cases:  Parties seeking review…

…also provides for reports to Congress for delays in issuing proposed or final regulations; civil penalties for violations; and incentives for State enforcement of federal requirements.     The Healthcare Distribution…

A recent Federal Trade Commission (“FTC”) action serves as a reminder that the agency takes seriously cases referred to it by the National Advertising Division of the Council of the…

…to children’s products, including lead.  It also contains provisions relating to the administrative functions that have been delegated to the United States Consumer Product Safety Commission (“CPSC”), enhances the authority…

…§ 402(j)(1)(A) defines an “applicable drug clinical trial” to mean “a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug subject to [FDC Act § 505]…