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…investigational devices should be covered under Medicare. The process was based on placing devices into one of two categories: Category A, for “Experimental/ Investigational” devices, or Category B, “Non-experimental/Investigational” devices. …
…SBA component to which this blogger has always paid close attention is the “Exclusivity Summary” (also sometimes referred to as the “Exclusivity Checklist”). The earliest version of that document we…
…here. The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed…
…aligned sense of the status quo. It may also provide an opportunity to identify and discuss potential differences in opinion between the two parties early in development. Mid-to-Late Stage Clinical…
…and resources necessary to obtain approval for commercial marketing or use. That was the case in the PTO’s April 3, 1995 decision denying a PTE as to U.S. Patent No….
…more immediate and aggressive enforcement action by FDA. Against traditional pharmaceutical manufacturers, FDA has, in its armamentarium, civil (e.g., TRO, seizure) and criminal (FD&C Act prosecution) judicial actions that can…
…the sting of making the payment can be severe. A question many ask is, “Can we deduct on our federal tax return any monetary payment we make to the government?”…
…Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.” Both chapters cover essential elements of development and approval of pharmaceutical products in the United States. The “FDA Regulatory Scheme”…
…NDA applicant and determined by FDA to be essential to the approval of the NDA (or Supplemental NDA) support the approval of a new indication or use for the NDA’d…
By Ricardo Carvajal – Given the effort that FDA has put into FSMA implementation thus far, it comes as no surprise that the agency’s budget for 2016 places a heavy emphasis on…
…Jennifer M. Thomas, and Anne K. Walsh, will reference key sections from the book as they walk through a case study of a scenario facing a hypothetical medical device company…
…technology. Despite all the attention that has come to CRISPR and gene editing in general, many legal questions linger; it is not immediately clear how the FDA and USDA will…
…comprised of parts that are physically, chemically, or otherwise combined into a single product) combination products, Part 4 provides an alternative to the general rule: a facility can elect to…
…addition of new “exemptions” of research based on the level of risk they pose to participants was retained in the Final Rule, largely for categories of social and behavioral research….
…articles and reference publications. While some guidance was better than no guidance, FDA received several comments asking for clarification on how the principles applied to medical textbooks, and also received…