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…they aren’t compounded in strict compliance with the FDCA. Finally, the draft guidance, which is explicitly not binding, also tells compounders that compounding must be performed in compliance with applicable…
…Energy and Commerce Committee – FDA did not address concerns about GDUFA user fee burdens on small companies, based on a quick look at the preliminary hearing transcript.) The penalties…
…about suspicious prescriptions received at the pharmacy. However, DEA found that the pharmacist had otherwise misrepresented her involvement and culpability in filling prescriptions that were not for a legitimate medical…
By Dara Katcher Levy – A new Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) suggests that FDA may want a new fight when it comes to…
…v. Bartlett, 133 S. Ct. 2466 (2013) (No. 12-142). On Friday, November 8, 2013, the wait was over. FDA’s Proposed Rule would allow generic manufacturers to independently update product labeling…
…to require, among other things, a pharmacy to notify a prescriber within 5 business days whether the prescription dispensed was a biological product or an interchangeable biosimilar (or enter the…
…central pharmacy that encompasses steps such as interfacing with financial businesses, such as insurance companies, in order to secure payment for the prescription, rendering them incidental to a financial product…
…the U.S. Court of Appeals for the Sixth Circuit issued its decision in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Case Nos. 12-5368, et al. (6th Cir. June…
…“no” votes, with half of the “yes” votes coming from Republicans and the other half coming from Democrats. We have blogged on the 21st Century Cures Act here and here. …
…the company name in the same form as it appears on the license) 2) Address of the facility 3) All trade names that the company does business as (i.e., any…
By David C. Gibbons – In a letter sent to Acting FDA Commissioner Ostroff on May 27, 2015, the House Committee on Energy and Commerce (“EC Committee”) informed FDA that…
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a…
…March 11, FDA announced its draft guidance entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.” Despite the amount…
…available because of competing public health priorities (e.g., anthrax, Ebola, influenza); An advisory committee meeting is needed for reasons such as clinical trial results or safety issues; An unanticipated safety…
…the Balanced Budget and Emergency Deficit Control Act of 1985 – the law first establishing sequestration procedures – to exempt user fees collected pursuant to FDC Act Sections 736 (Prescription…