…the reference product sponsor and the ANDA sponsors cannot come to an agreement on the system, which may delay the approval of an ANDA until such an agreement can be…

…immunogenicity studies may not be required. While this isn’t the case for all biosimilar or interchangeable insulin products and FDA will analyze on a case-by-case basis for individual applications, the…

…can be readily answered” based on the FDA reviewers “experience or knowledge” and that “do not require additional background information, an in-depth review, or other FDA staff involvement” can be…

…824 to settlements executed outside of California and between non-California entities almost would certainly be unconstitutional: if the [California] Attorney General were to enforce the terms of AB 824 against…

…drug that was already available outside the U.S.), requiring a plan to provide access to the drug if PRV was awarded in connection with its approval, limiting companies eligible for…

Californovation (sung to the tune of the Red Hot Chili Peppers’ Californication, obviously): the new portmanteau seems appropriate for California, who just keeps coming up with new ideas to address…

…of the draft labeling,” such a justification of why certain clinical trial information can be carved-out without raising safety or efficacy issues. When ready to add such a carved-out condition…

…final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May 2016. The rule is designed to…

…visits, consider alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location). If in-person visits are not possible, and safety of trial participants cannot be assured by alternative…

…regulates alcohol, but it is part of a complex system of both federal and state regulation. At the federal level, the TTB is joined by the FDA, USDA, FTC, and…

…proposed rule “if the changes in the original plan ‘are in character with the original scheme,’ and the final rule is a ‘logical outgrowth’ of the notice and comments already…

…deviations and amendments, helping navigate a number of contingency measures (e.g., initiating virtual visits, switching to home delivery or infusion of the investigational product, alternative monitoring), and documenting informed consent…

…safety. Naming of the final products is also uncertain. As we have previously reported, the traditional (animal) industry (and farmers) has opposed naming the cell-based products using terms that have…

…The listing of patents associated with an established REMS; and The listing of patents associated with digital applications (e.g. clinical decision support software, software as a medical device). FDA also…

…can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: mission critical inspections only, all inspections with caveats to help…