…Lovaza’s single-active-ingredient mixture, it denies exclusivity.  The decision’s sole acknowledgment of the apparent divergence between the statutory and regulatory inquiries is both minimal and confounding.  In the course of its…

…figure when it paid Knight Therapeutics Inc. $125 million for its Tropical Disease PRV.  Another Tropical Disease PRV FDA granted with the 2012 approval of SIRTURO (bedaquiline) for tuberculosis has…

…The provision at issue is in Section 1222 (titled “Capturing Lost Opportunities and Creating New Cures for Patients”) of Subtitle M (titled “Dormant Therapies”).  It states: (C) EXTENSION OF PATENTS.—…

…to medical device data systems (MDDS), medical image storage devices, and medical image communications devices.  In line with the draft guidance, on which we blogged here, FDA has confirmed its…

…as there are no additional studies performed for which the reward serves as an incentive. Effectively, all biosimilars could be interchangeable with the right explanation, which leaves questions of whether…

…POM’s ads made misleading or false claims. Id. at 3. This conclusion was not altered by the fact that POM had spent more than $35 million on pomegranate-related medical research,…

…because it is most similar to MITIGARE – Judge Jackson analyzes various FDA responses to relevant Citizen Petitions and uses them to pick apart Plaintiffs’ argument: [T]heir argument hinges on…

…allege that FDA and FWS violated various statutes, including the FDCA, the Administrative Procedures Act (APA), the National Environmental Policy Act (NEPA), and the Endangered Species Act (ESA).  Without going…

…Although FDA and USDA-FSIS are the two federal agencies that generally regulate mandatory labeling requirements for foods, the bill gives the USDA Agricultural Marketing Service (AMS) the responsibility for establishing…

…601 delineates those changes as being either major, moderate, or minor. Major changes may have a substantial effect on quality and require a Prior Approval Supplement (PAS). The draft guidance…

…guidance. This could include categories of animals or types of genetic changes that are likely to pose minimal risks to the animal, to food safety concerns, or to the human…

…seven synthetic flavoring substances, and to prohibit their use. The petition contends that the substances have been found to induce cancer in man or animal by the National Toxicology Program…

…opposition is expected from the tobacco industry, including legal challenges to the rule, if finalized. Even if the rule ultimately survives any such challenges, whether FDA will also attempt to…

…to identify and coordinate with companies that have manufacturing facilities in Puerto Rico to assess the potential impacts on their facilities to avoid—whenever possible—shortages of critical medical products. During and…

…and cellular networks”; “The availability of landline telephones in retail stores”; “Challenges facing small and rural retailers”; “[E]fforts that retailers and others have taken,” thus far, “to address potential technology…