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We have blogged recently about several FDA setbacks in court (here, for example). Add one more to that tally. Genus Medical Technologies secured an important victory in the D.C. Circuit…
…the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic dietary supplements.” In support of that request, the petition argues in part that: A…
…amounts.” FDA’s draft guidance attempts to define the scope of “regularly or in inordinate amounts.” FDA’s draft also defines “commercially available” and “essentially a copy of a commercially available” drug. …
…on how the case will turn out, the U.S. Supreme Court this month heard oral argumentsin AMG Capital Management v. Federal Trade Commission. Karin’s blog post has more details. …
…the DQSA’s provisions to the case at hand. So back to the DC District Court we go . . . and perhaps someday appealed again up to the DC Circuit….
…oral presentations.” Requests to present orally at the first meeting should be submitted by February 8, and oral presentations will be limited to three minutes. The deadline for advance registration…
…as Justice Breyer commented during the argument, “Blue brief I think you’re right. Red brief I think you’re right. You can’t both be right. That’s right. Alright. You see, that’s…
…Inc.). Now that the FTC Staff and POM have made their written arguments, the next step in the process is for the five FTC Commissioners to hear oral argument and…
…C.F.R. § 1308.11 (d)(31)(ii). THC in hemp. 21 U.S.C. § 812(c)(17); 21 C.F.R. § 1308.11(d)(31)(ii). CBD and products derived from parts of the Cannabis sativa L. plant excluded from the…
…and Recovery Act of 2016, Pub. L. No. 114-198, 130 Stat. 695 (codified as amended in scattered sections of 42 U.S.C. and 21 U.S.C.). DEA has now proposed a rule…
…the Supreme Court. See Brief for the Federal Respondents, State of California, et al. v. State of Texas, et al., Nos. 19-840 and 19-1019. If the suit is successful, this…
…Ipsen Biopharmaceuticals, Inc. v. Azar, Ipsen had obtained approval in 2007 for Somatuline Depot for the treatment of acromegaly. In 2014, FDA approved two supplemental NDAs (sNDAs), one for changes…
…manufacturer for failure-to-warn is not preempted. So here’s a run-down of the latest, including where things stand in the Bartlett case . . . . Demahy v. Schwarz – Petition…
…list or the Excel database. . . or perhaps both). The list certainly comes in handy when speculating about the prospects of 5-year NCE exclusivity (see our previous post here)….
…“narrowly tailored” to serve a “compelling governmental interest.” The FDA appealed, and the D.C. Circuit agreed to hear the case en banc. All 10 judges on the D.C. Circuit participated…