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…animal drugs for minor use and minor species – FDC Act § 571 – and to marketed unapproved new animal drugs for minor species – FDC Act § 572 – but we…
… And the agency abandoned without reason or explanation the previous position that it had applied to other applicants. [(Emphasis in original)] Although Boehringer goes through the two-step Chevron analysis in…
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article…
…heels of losing the PI Motion, may believe it is likely to lose the case on the merits if the case proceeds to final judgment. Settlement may allow FDA to…
…allege that FDA and FWS violated various statutes, including the FDCA, the Administrative Procedures Act (APA), the National Environmental Policy Act (NEPA), and the Endangered Species Act (ESA). Without going…
…studies that have become available. However, according to FDA, there is still no scientific basis to set a DRV for total sugars. FDA’s supplemental proposal also addresses the footnote in…
…are only two narrow statutory bases for changes to the SPA – written agreement between FDA and the sponsor or where FDA finds a “substantial scientific issue essential to determining…
…makes explicit that LDTs are, in FDA’s view in vitro diagnostic devices subject to FDA regulatory oversight, and always have been. With the Final Rule’s publication on Monday, May 6,…
…Drugs, Royal Copeland, and Federal Drug Regulation.” When attempting to regulate homeopathic preparations, the agencies are forced to address questions they never face with other regulated products, such as: How…
…Lovaza’s single-active-ingredient mixture, it denies exclusivity. The decision’s sole acknowledgment of the apparent divergence between the statutory and regulatory inquiries is both minimal and confounding. In the course of its…
…figure when it paid Knight Therapeutics Inc. $125 million for its Tropical Disease PRV. Another Tropical Disease PRV FDA granted with the 2012 approval of SIRTURO (bedaquiline) for tuberculosis has…
…The provision at issue is in Section 1222 (titled “Capturing Lost Opportunities and Creating New Cures for Patients”) of Subtitle M (titled “Dormant Therapies”). It states: (C) EXTENSION OF PATENTS.—…
…to medical device data systems (MDDS), medical image storage devices, and medical image communications devices. In line with the draft guidance, on which we blogged here, FDA has confirmed its…
…as there are no additional studies performed for which the reward serves as an incentive. Effectively, all biosimilars could be interchangeable with the right explanation, which leaves questions of whether…
…POM’s ads made misleading or false claims. Id. at 3. This conclusion was not altered by the fact that POM had spent more than $35 million on pomegranate-related medical research,…