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…27 (D.D.C. 2001) (here) . . . and that case didn’t turn out too well for FDA. (Of course, there was the initial case of National Pharmaceutical Alliance v. Henney,…
…guidance addressing 505(q) petitions, FDA is continuing to address the issue. As part of the Commissioner’s Drug Competition Action Plan to increase prescription drug competition and facilitate access to affordable…
…point of 2018 and reminisce about a simpler time, we’ll probably look back on 2018 as a simple time from the vantage point of . . . let’s say 2024….
…data in the recommended format. The reduced review time will likely be worth the extra effort. It is hard to predict if the new program will result in an increase…
…House Versions Of “The Greater Access To Affordable Pharmaceuticals Act,” Hearing Before The Sen. Jud. Comm., at 116 (Aug. 1, 2003) (prepared statement of the Hon. Timothy Muris, Chairman of…
…Inc., with locations in Rancho Mirage and Beverly Hills, California; the Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D. personally, from…
…the PAS or at any time thereafter. For instance, if OPQ receives a request for expedited review after the office has already processed the PAS, OPQ will consider the request…
…sales programs. This D.C. Circuit decision comes just before this deadline – right in time for the withdrawal to take effect as scheduled. As we explained in a 2014 blog…
…class‑wide approach, and solicit comments? Practical questions come to mind. If a PMA‑holder complies with the Quality System Regulation (QSR) for device manufacturing, would they be required to revamp their…
…acknowledging that no one set would fit every company. The panels at the workshop provided interesting perspectives on how a precertification program would be understood and received by their communities….
…. . . is approved.” Id. Alternatively, manufacturers could produce commercial scale batches of finished drug product outside the U.S. and import them into the U.S. once the NDA is…
By James R. Phelps & Kurt R. Karst – On November 17, 2008, Representatives John Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman…
…adulterated or misbranded product has been received or been released into commerce. FSIS specifically requests comments whether 48 hrs is an appropriate time frame. The proposed rule also includes a…
…imposed.” 37 C.F.R. § 1.183. Since the USPTO has corrected its methodology of counting the time period of 35 U.S.C. § 156(d)(1) to conform with the express language of the…
…with adequate bulwarks.” Bantam Books, Inc. v. Sullivan, 372 U.S. 58, 66 (1963). At this point, such a time limit is missing. While Congress has charged the FDA with “establish[ing]…