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…Stryker Orthopedics, Inc.) resolving anti-kickback allegations. The allegation common to all five cases is that each of the companies entered into consulting agreements with orthopedic surgeons under which the companies…
…based on the fraudulent, inflated prices, the government contended that Aventis caused false and fraudulent claims to be submitted to federal health care programs, thereby violating the FCA. In exchange…
…total of $102 million (one of the whistleblowers will receive more than $51.5 million). First, on the criminal side, Pharmacia agreed to plead guilty to a felony violation of…
…has actively and deliberately targeted a greater number of well-known, national brands. All advertisers under FTC jurisdiction are well-advised to review their use of online disclosures sooner rather than later. …
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…
…exclusive approval, as appropriate, for those additional subsets from the date of such additional marketing approval(s). Before obtaining such additional marketing approval(s), the sponsor in this instance would not need…
…a not-for-profit, global organization dedicated to bringing health care product development professionals together in a neutral environment to improve health and well-being throughout the world. The conference focuses on the…
…Performance Goals and Procedures Fiscal Years 2023 Through 2027). FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition…
…for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies. 21 U.S.C. § 823(f). The Act also established new definitions for “Internet,” “online pharmacy,”…
…how to decide whether a disclosure is necessary in the first place—although several panel members did express opposing views about the need for disclosures, consumer expectations for digital media, etc. …
The first anniversary is always special. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future. The first anniversary can also prompt a taking…
…to offer the qualifying product at a “reasonable price” (as defined in the bill) and to publicly disclose all pre-clinical and clinical trial data relating to the product, the award…
…Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for…