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…Act (FCA). The relator (an LLC named “The Dan Abrams Company LLC” formed by a former Medtronic employee named Bryan Shapiro) alleged, inter alia, that Medtronic obtained marketing approval for…
…be taken against a drug manufacturer’s proposal to replace products that require specialized handling that could not be administered to patients for certain reasons, at no additional charge to the…
…to patents covering drug-device combinations.” Taking the opposite approach, AstraZeneca, Boehringer Ingelheim, Abbvie, Mylan/Viatris, and Teva all refused to delist the patents referenced by FTC and Congress. Each made similar…
…cannabis to schedule III, federal law will more closely align with that of the thirty-eight states that currently allow for some form of cannabis for medical use but would still…
…therapeutic category and perhaps also within therapeutic categories; surrogate endpoints can shorten the clinical testing period; and certain types of product will generally require a longer research and development period….
…(e.g., manual surgical instruments). In order to create additional granularity with regard to device technology within each classification regulation, FDA created product codes. There can be one or many product…
…though!), and can get quite technical at times. But we try to spice things up when we can with pop culture references and attention-grabbing headlines. Where else would you see…
…Case-by-case No 12/28/16 Final Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Notice of Availability Case-by-case No 12/28/16 Draft Guidance (Comments due February…
…other rapid communication means, with prompt written followup. The report and its mailing cover should be plainly marked: “NDA – Field Alert Report.” (i) Information concerning any incident that causes…
…54 Fed. Reg. 28,872, 28,898-99 (July 10, 1989) (“[T]he agency interprets [5-year NCE exclusivity] to cover any subsequent approval of an application or supplemental application for a different ester, salt,…
…to determine if the change can be submitted as a Special 510(k). The Special 510(k) Program Guidance provides an example of a change involving the addition of wireless control capabilities…
…explicitly includes all animals whose genomes have been intentionally altered, no matter how the alternation occurred. The prior version, on its face, was limited to animals genetically engineered by rDNA…
…FDC Act § 505(j)(5)(D)(i)(I)(bb) permits a “mix-and-match” approach in addition to an “all-in-one” approach. Under the “all-in-one” approach, the parenthetical “(which other applicant has received tentative approval)” provides that the…
…Medicare Modernization Act), terms fundamental to Hatch-Waxman and ANDA submissions that have for many years been misunderstood or misused (by FDA and the pharmaceutical industry). Those terms are “Reference Listed…
…Covered Entity does not identify the purchase as 340B-eligible at the time the purchase is made. Furthermore, Covered Entities are not permitted to reclassify a purchase as 340B eligible after…