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…chemical action makes the greatest contribution to the therapeutic effects. Absent such evidence, presumably the OCP would revert to the portion of the algorithm in its regulations applicable to cases…
…under this section may be used for obtaining approval under an NDA or BLA, or supporting investigational use of a drug or biologic under an IND. The section also allows…
…apply to devices intended for use in professional health care facilities, such as hospitals, nursing homes, clinical laboratories, or physician offices. The label and package insert would be electronically submitted…
…October 6, 2016, FDA published in the Federal Register a Final Rule, titled “Abbreviated New Drug Applications and 505(b)(2) Applications,” that will forever alter the Hatch-Waxman landscape, and that will…
…in the management of their disease, and (c) experimental designs for patient-reported outcomes. FDA is also asked to include timeframes for review of documents containing this information and how it…
…official debut in the Federal Register. The pre-publication version of the proposal is a massive 341 pages (and includes a slew of tables), while the official version printed in the…
By Michelle L. Butler & Alan M. Kirschenbaum – On August 3, CMS issued final versions of three agreements to implement the Medicare Coverage Gap Discount Program. We previously described…
…and also includes a proposed chapter on intellectual property. That proposed chapter is where the debate over biologics exclusivity is happening. A July 27, 2011 letter signed by several members…
…a . . . sham request in a petition can cause antitrust damage above and beyond the delay caused by the non-sham claim – i.e., that the injury will exceed…
…to humans. Also, FDA may cancel the registration if, after a notice of cancellation, the establishment has not updated its registration. There is no requirement for registration fees. The registered…
…Promotion for Medical Products Committee John Claud, Counsel, Enforcement, Litigation, and Compliance Conference Planning Committee Mark Tobolowsky, Associate, Food and Drug Law Journal Advisory Board Philip Won, Associate, New to…
…manufacturer. The complaints allege that the drug companies’ interference with insurance cost-sharing arrangements violates federal law. First, the complaints allege that the pharmaceutical companies’ co-pay coupon programs constitute substantive RICO…
…by the IOM reached several broad conclusions detailed in the report: Pediatric studies conducted under BPCA and PREA are yielding important information to guide clinical care for children. Information from…
…not only those subject to 510(k) notification or PMA approval, but also “devices that are legally marketed for a specific intended use without an individual product approval or substantial equivalence…
By Kurt R. Karst – Less than a month before the U.S. Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Docket…