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    Month: June 2018

    • The Mutual Recognition Agreement Rolls Along – But Where is Germany?June 22nd, 2018

      Earlier this month the FDA recognized the drug inspectorates of Ireland and Lithuania for purposes of the Mutual Recognition Agreement (MRA), and in March of this year, the agency recognized the drug inspectorates of Greece, Hungary, the Czech Republic and Romania. Indeed, it was last October …

    • FDA Issues First Installment of Guidance on Intentional Adulteration RuleJune 21st, 2018

      The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May, 2016. The rule is designed to address hazards that may be intentionally introduced to foods, including by acts of …

    • Like Ma Bell, I’ve Got the Ill Communications: Final Guidances IssuedJune 20th, 2018

      Announced as another effort to improve patient access and address drug pricing, FDA recently finalized two guidance documents intended to facilitate better communication and negotiation with payors, formulary committees, and others: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance …

    • DEA Issues Decisions in Pharmacy CasesJune 18th, 2018

      Over the last couple of months, DEA has issued four decisions revoking the registrations of pharmacies (recall that DEA issued only one decision in 2017 involving a pharmacy). In February 2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 …

    • Stop, Collaborate, and Listen – Or Get a WaiverJune 15th, 2018

      In an attempt to ensure that implementation of the FDCA requirement for shared REMS does not cause undue burden, FDA released two new guidance documents targeting shared REMS systems. We have seen the negotiation of shared REMS systems succeed – and fail spectacularly resulting in waivers. …

    • The Eleventh Circuit Avoids Opining on the FTC’s Authority to Police Negligent Data Security Practices in HealthcareJune 14th, 2018

      On June 6, the Eleventh Circuit vacated the Federal Trade Commission’s (“FTC’s”) data security-related cease and desist order against LabMD, Inc. (“LabMD”), a diagnostic testing company. The decision was less than satisfactory for many amici who had called on the Court to opine – one …

    • DEA, Nunc Pro Tunc Rulings, and Hearings That Never HappenedJune 13th, 2018

      A couple of months ago, the DEA Acting Administrator issued an order revoking the registration of David A. Ruben, M.D., on the grounds of lack of state authority (the Arizona Medical Board suspended his medical license in 2017). The same doctor was the subject of …

    • FDA Finalizes 510(k) Exemptions for Certain Class II DevicesJune 12th, 2018

      On June 5, 2018, FDA published a notice in the federal register finalizing the 510(k) exemption for several devices. The proposed list for 510(k) exemption was published last November and included two new devices that had been granted marketing authorization through the de novo process …

    • FDA Narrows Interpretation of “Same Product as Another Product” under PDUFA VI; 505(b)(2) Applicants Will Primarily be AffectedJune 11th, 2018

      Over the years, we’ve been critical at times of FDA policies and regulations that cause companies to have to pay user fees under the Prescription Drug User Fee Act (“PDUFA”) (see, e.g., “FDA’s Unauthorized User Fee Money Grab” and “The Drug User Fee Catch-22”)  Well, …

    • Burden of “Right to Try” Implementation on Sponsors (for Now); Risk of Unexpected SAEs Negatively Impacting Development and Approval Still RemainsJune 8th, 2018

      On May 30, 2018, the federal “Right to Try” law was enacted, creating a new legal framework for access to investigational drugs in limited situations outside of a clinical trial. See S. Rep. No. 204, 115 Cong. (2018). “Right to Try” was intended to reduce …

    • CDRH Issues Draft Guidance Regarding Test Reports for Nonclinical Bench Studies in Premarket SubmissionsJune 7th, 2018

      On May 31, 2018, CDRH issued the draft guidance, “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.” The draft guidance is intended to provide an outline of the type of information to be included in non-clinical bench …

    • Connecticut Becomes Seventh State to Enact Drug Price Transparency LawJune 6th, 2018

      With the enactment of Public Act 18-41 on May 31, 2018, Connecticut joined the growing list of states (see our posts here and here) requiring drug manufacturers to submit reports on price increases. Three different reporting requirements are imposed on manufacturers under the law. First, …

    • FDA Draft Guidance for GRAS Panels: Unintended Consequence?June 5th, 2018

      Much to our surprise, we found the following recommendation for GRAS Panel members in FDA’s draft Guidance on GRAS Panels issued in November 16, 2017:  . . . avoid filling a gap in the available data and information through theoretical considerations and relevant experience – e.g., …

    • FDA to Modernize Drug Review Office Structure and ProcessesJune 5th, 2018

      On June 4, 2018, FDA posted a statement from CDER Director Janet Woodcock announcing a multi-pronged FDA initiative to modernize FDA’s drug review offices and processes.  The initiative will involve: Staffing increases Increasing the number of review offices from the current 5 to 9 and the review …

    • Fifth Delay for 340B Final Rule ImplementationJune 4th, 2018

      On June 1, 2018, the Health Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the 340B Drug Discount Program (“Substantive Final Rule”). The Substantive Final Rule, which was originally …

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