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…in the Federal Register a “proposed program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form.” 82 Fed. Reg. 60922, 60922 (Dec. 26, 2017). This…
By John R. Fleder – It is hardly a secret that FDA’s favorite regulated industry is certainly not the businesses that compound pharmaceutical products. For years FDA has struggled to…
By Ricardo Carvajal – Kellogg Company has agreed to FTC’s expansion of the settlement order that the company entered into in July 2009 regarding false claims that Frosted Mini-Wheats improve…
…retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision and order in which the Commission ordered QVC to cease representing certain products…
…committee dedicated to the review of ETASU. In the interim, Kaiser suggests that advisory committees (with a health care provider member) reviewing drugs that will likely receive ETASU also have…
…a similar provision related to the section 156(d)(1) 60-day filing window compels the conclusion that Congress did not intend the provision to be remedial, or to be interpreted in a…
…to the opioid abuse epidemic; Controlled suspicious order legal and regulatory requirements; DEA enforcement actions for suspicious order violations; The Masters Pharmaceutical decision; The Support for Patients and Communities Act…
…ingredient if the company failed to provide information to FDA as required under the bill or if the company’s products contain non-permitted ingredients; Require responsible parties to notify FDA if…
…Columbia, August 6, 2010 (“Complaint”) at 3, 5. FDA’s Complaint states that the Regenexx Product is a drug under the FDC Act as it is intended to cure, treat and…
…summary, the district court dismissed PhRMA’s original Complaint on procedural grounds, without prejudice, granting PhRMA leave to amend its Complaint within 30 days. Granting, in part, California’s Motion to Dismiss,…
…are competitive with the MFN Drug Payment Amounts.” (85 Fed. Reg. at 762280) The essential features of the MFN Model are outlined below. Performance Period: The MFN Model will be…
…that ruling to the five member Federal Trade Commission. Further briefing ensued. Once that briefing had been completed, the regular season ended. It was on to the playoffs. The next…
…face is sufficiently complete to permit a substantive review and clarify that “sufficiently complete” means that the ANDA contains all the information required under section 505(j)(2)(A) of the FD&C Act…
…Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which created a narrow statutory exemption to the CSA’s “ultimate user” definition that authorizes the…
By Karla L. Palmer – A very busy House Energy and Commerce’s Subcommittee on Health (chaired by Joe Pitts (R-PA)) held a hearing earlier this week to review six bi-partisan bills intended to…