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…settlement agreements. According to the FTC, “[o]ne of the Commission’s top priorities is putting an end to anticompetitive pay-for-delay patent settlement agreements.” Indeed, the Commission commented in its January 2010…
…also create complexities for manufacturers, who must wrestle with determining if a complaint is a malfunction (not all are), and whether a malfunction is reportable because it would be “likely”…
…a month after the FTC issued its report, titled “Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions,” in which the Commission analyzed the effects of settlement agreements in the drug…
…as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its…
By Susan J. Matthees – Last week FDA published a memorandum titled “FDA Comments on Symbols Public Hearing and Current Plans for Addressing Issues.” The memorandum responds to questions and…
…ingredients and improving FDA’s communications and feedback with industry in order to expedite product access.” The agreement reached between FDA and the generic drug industry is complex (to say the…
…for line extensions of oral solid dosage form innovator drugs, not only to new formulations, but new indications, combination products, and products marketed by companies independent of the company marketing…
…on acceleration of the development of nanomedicine. Further information and registration information is available here. FDA Law Blog readers can use the code NANOMED25 to receive 25% off the cost of registration….
…CSPs in house including complying with USP <797>. The Report notes that USP <797> compliance is difficult and resource intensive; cost and space limitations are “major challenges” for half of…
…exchanges, cost-sharing reductions or premium tax credits to enrollees, consumer oriented and operated plans (“CO-OPs”), or federal risk adjustment, reinsurance, or risk corridor programs. According to Secretary Sebelius, HHS’ decision…
…companies’ views on burdens to the companies involved and other single, shared system issues. Brand companies are also free to provide FDA with input about the appropriateness of a single,…
…Competition and Innovation Act of 2009 (“BPCIA”). Although FDA has not yet approved a biosimilar biological product (or even accepted a biosimilar application), there has been a significant push in…
…lines for when reviews will be completed, when letters will be issued, or when other actions will be taken. Because workload and competing priorities affect action times, time lines are…
…adherence communications to patients about their prescribed treatment regimens, and is paid for by pharmaceutical companies, can continue to provide its services under the Omnibus Final Rule. In its complaint,…
…Health-System Pharmacists, and Retail Association of Maine – and two pharmacists, filed a Complaint and Motion for Preliminary Injunction in the U.S. District Court for the District of Maine against…