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…the model, and in June 1999 presented a concept paper to the Pregnancy Labeling Subcommittee of the Reproductive Health Drugs Advisory Committee. Based on the advisory committee’s recommendations, FDA further…
…take the request for publication of the metrics back to management. We note that FDA has communicated metrics from time to time. For example, at the Association of Medical Diagnostics…
…the U.S. Constitution and violates 42 U.S.C. § 1983. These are the same counts alleged in the Alameda County lawsuit. According to the Complaint: The Regulation represents a per se…
As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money. A lot of it. When that happens, there are always immediate…
…additional resources, prior to receiving a complete response letter (CRL) stating for at least the fourth time that the endpoint was inappropriate. An appeal is still not available. The sponsor…
…word “shall” generally indicates that the directive is mandatory. See Nat’l Ass’n of Home Builders v. Defs. of Wildlife, 551 U.S. 644, 661–62 (2007); Lopez v. Davis, 531 U.S. 230,…
…weeks to compile completed data into a functional EUA submission and submit while also committing to a triage review with a tiered approach to deficiencies. Hundreds of companies took advantage…
…31, 2019. The link to submit comments on the CMS proposed rule can be found here. The link to submit comments on the OIG proposed rule can be found here….
…have ramped up our decisions. So we are currently over the last week averaging about nine decisions. That’s N-I-N-E, nine a day. While we were initially encouraged by this update…
…relevance of patent information submitted to . . . and published by FDA.” As part of that requirement, FTC must have described the specific grounds for disagreement for each patent,…
…final rule takes effect, domestic and imported “catfish” will be subject to FSIS jurisdiction. As a result, “catfish” slaughter will be subject to continuous inspection. Labels for “catfish” and “catfish”…
…on state sovereign immunity. NiGen timely appealed and in the case of NiGen Biotech, L.L.C. v. Paxton, No. 14-10923, 2015 WL 5749618 (5th Cir. Sept. 30, 2015), the court reversed in…
…920 F.2d 984 (D.C. Cir. 1990) (here). If a drug product contains any previously approved active moiety (i.e., if it is not composed of all NCEs), then FDA historically denied…
…www.fdalawblog.net. Friend-of-the-blawg briefs are due no later than 11:59 p.m. CT on August 16, 2015. ABA editors make the final decisions about what blogs to include in the Blawg 100. …
…of 180-day exclusivity. See, e.g., Ranbaxy Labs., Ltd. v. Leavitt, 459 F. Supp. 2d 1, 3-4 (D.D.C. 2006). Ultimately, we cannot Predict whether the Amarin case will be settled or,…