…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…

…and the pregnancy and lactation labeling rule, regardless of whether the labeling of the reference product does or does not follow those rules. Turning to specific issues, FDA states that…

…series of high-level “yes” or “no” questions to be answered by the app developer. The answer to any individual question directs the user to a subsequent question, and ultimately informs…

…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 The draft guidance…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…

…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…

…labeled as ‘Harmful or fatal if swallowed’ and ‘Keep out of reach of children.’ You also manufacture other toxic non-pharmaceutical industrial and automotive care products, such as leather treatments…Leather Care,…Leather…

…long been incorporated in medical devices and subject to traditional regulation (Software In A Medical Device, or SIMD). And early iterations of software as a medical device (SAMD) fared reasonably…

…basis for summary disposition on the material falsification issues, all registrants, including manufacturers, distributors, and practitioners, should be on notice of DEA’s potential use of summary disposition on material falsification…

…tentatively approved first applicant who has requested final approval is determined by the Secretary to be eligible for effective approval by meeting all the approval requirements of this subsection, such…

…and Critical Care Medicine Journal, a bi-weekly peer-reviewed medical journal published by the American Thoracic Society. The page in the brochure calls out that the data were also included in…

…for the evaluation of device performance. There are academic studies, journal articles, disease‑focused societies, symposia, conferences, case studies, clinical guidelines, talks by key opinion leaders, and a host of other…

…disoproxil fumarate) Tablets, NATAZIA (estradiol valerate and estradiol valerate/dienogest) Tablets, ANORO ELLIPTA (umeclidinium bromide; vilanterol trifenatate), and NUVARING (ethinyl estradiol; etonogestrel) as examples that “demonstrate that a single-entity drug substance’s…