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…the company’s Motion for a Temporary Restraining Order and Preliminary Injunction is under seal, so there’s not a lot for us to go on. The Complaint does reference, however, a…
…in order to comply with the order of an individual physician or dentist” or other specified healthcare practitioner; Must deviate from a requirement of section 514 or 515 in order…
…order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation”…
…comply with section 904(d)(1) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which requires FDA to publish a list of HPHCs, by brand and by quantity in each…
By Jennifer D. Newberger – On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the…
…Fed. Reg. 8432 (Jan. 25, 2017) Donald W. Lamoreaux, M.D., 82 Fed. Reg. 8434 (Jan. 25, 2017) Richard W. Walker, Jr., M.D., 82 Fed. Reg. 9223 (Feb. 3, 2017) Janet…
…means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5. FDA purportedly approved Augment Bone Graft on September 1, 2015 under Premarket…
…exclusivity], Amgen shall respond to the reconsideration decision by July 3, 2017; and FDA shall issue a decision on dispute resolution by August 2, 2017,” says the Order. If FDA,…
…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….
…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…
…e.g., In re POM Wonderful, LLC, 155 F.T.C. 1 (2013), aff’d as modified, 777 F.3d 478 (D.C. Cir. 2015) (FTC order clarifying policy on health claim substantiation); In re 1-800…
…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….
By JP Ellison & Ricardo Carvajal – A Massachusetts district court has ordered marketers of calcium and herbal supplements touted as effective in preventing, treating, or curing diseases such as cancer,…
…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,…
…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…