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By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because,…
…of Qualifying Tropical Diseases On August 20, 2015, FDA published a final order to add two new diseases, Chagas disease and neurocysticercosis, to the list of qualifying tropical diseases. Recall…
…reflected the November 11, 2009 date, FDA nevertheless approved an ANDA on November 10, 2009. (Consistent with the court’s order, the generic version was presumably not launched until November 11, 2009.)…
…including Monday, May 11, 2015, to and including Friday, June 3, 2016) is far too long a period. “In recent cases with expedited briefing, as is the case here,” notes…
…provide this information. Investigators ask about controlled substance security including who has access to the vault, cage, and safe, system components and specifications, internal inspection results, alarm test results, and…
…Medications Act of 2017, 85 Fed. Reg. 62,634 (Oct. 5, 2020). Electronic comments on the proposed rulemaking must be submitted, and written comments postmarked, on or before December 4, 2020….
…telehealth recommendations for medical marijuana, the provider must be licensed and in good standing as a medical doctor, osteopath, advanced practice registered nurse, dentist, naturopath, or physician assistant in DC,…
…basics: As with subpoenas and CIDs, the recipient of a 6(b) order may file a petition to limit or quash, and the Commission may seek a court order requiring compliance….
…Scientific Corp., 11-cv-02453, Dkt. No. 313 (D. Minn. Oct. 16, 2019). In this “disaster” of a case, Judge Rau sanctioned Defendant Boston Scientific Corporation (BSC) for failing to disclose a…
…Restraining Order, and scheduled a Preliminary Injunction Hearing for May 18, 2015. On Wednesday evening, Judge Hazel denied Otsuka’s Motion for Temporary Restraining Order and/or Preliminary Injunction. We were hopeful…
On December 20, FDA issued a new, draft guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways.” This guidance is the latest chapter in the years-long, and still on-going,…
…been high, as evidenced by the amicus briefs submitted by GPhA, Mylan, Teva, Apotex, Impax, and the Consumers Federation of America. FDC Act §505(j)(5)(C)(ii)(I) states that: If an owner of…
…citations omitted)] Interest in the Caraco/Sun petition will likely run high and may generate several amicus briefs. GPhA, Mylan, Teva, Apotex, Impax, the National Legislative Association on Prescription Drug Prices,…
…price controls.” Complaint at 10. The Plaintiffs “expected” their member, AbbVie, to be forced to enter negotiations with the Secretary, disclose competitively sensitive proprietary information about its drug, Imbruvica, and…
…metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses)….