FDA Regulatory and Compliance News

  • FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) supported, by a vote of 14 to 4, the safety and efficacy of Serenity Pharmaceuticals’ desmopressin nasal spray. Committee members who supported approval determined that the sponsor’s proposed indication for the treatment of adult onset nocturia was too broad, and preferred a narrower indication (e.g., adult nocturnal polyuria). (Tarius)
  • FDA’s Center for Biologics Evaluation and Research (CBER) announced that it will restructure after an internal review and create a new Office of Tissues and Advanced Therapies (OTAT), which was formerly known as the Office of Cellular, Tissue and Gene Therapies (OCTGT). Senior CBER leadership evaluated a variety of alternatives that would allow the center to more efficiently accomplish its regulatory mission, and the new CBER structure includes the Office of Blood Research and Review (OBRR), the Office of Vaccines Research, and Review (OVRR) and OTAT. [News Release] (FDA.gov)
  • FDA granted accelerated approval to Eli Lilly’s Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS). Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment. [News Release] (FDA.gov)
  • FDA’s Center for Biologics Evaluation and Research (CBER) announced release of an interim strategic plan for FY 2017 through 2019, offering the six overarching goals initially developed in 2011 with updated strategies to achieve them. The plan sets forth five overarching program goals and one final cross-cutting goal including: “Increase the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases,” “Improve global public health through international collaboration including research and information sharing,” “Utilize advances in science and technology to facilitate development of safe and effective biological products,” “Ensure the safety of biological products,” “Advance regulatory science and research,” and “Manage for organizational excellence and accountability.” [CBER Interim Strategic Plan FY 2017 - 2019] (FDA.gov)
  • FDA announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to bolster development of products for patients with rare diseases. The grants will be awarded through the Agency’s Orphan Products Clinical Trials Grants Program, which encourages clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases, and are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products. [News Release] (FDA.gov)
  • FDA proposed to amend its regulations revising the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). [FR Notice]
  • FDA issued a final order to reclassify the Upper Extremity Prosthesis Including A Simultaneously Powered Elbow And/Or Shoulder With Greater Than Two Simultaneous Powered Degrees Of Freedom And Controlled By Non-Implanted Electrical Components into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The special controls that will apply include: electronic input testing, software verification, validation, and hazards analysis, wireless testing, electromagnetic compatibility (EMC) testing, non-clinical performance testing. water/particle ingress testing. durability testing, battery testing, labeling, and biocompatibility assessment. [FR Notice]
  • FDA announced the availability of a guidance for industry entitled, “ANDA Submissions – Prior Approval Supplements Under GDUFA.” This guidance enables the Agency to assess user fees funding critical and measurable improvements to FDA’s generic drugs program, and provides assistance to applicants preparing submissions for prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). [Guidance] [FR Notice]
  • FDA proposed a rule implementing provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of device labels and package inserts of certain home-use devices when these devices are listed with FDA. The Agency plans to make this device labeling information available to the public through the Internet and would also provide search tools to facilitate locating data. [FR Notice]
  • FDA issued a final order to reclassify the apical closure device into class II (special controls). The special controls that will apply include: sterilization validation, shelf life testing, labeling, biocompatibility evaluation, in vivo performance testing, non-clinical performance testing, and training. [FR Notice]
  • FDA announced the issuance of a priority review voucher to Sarepta Therapeutics for EXONDYS 51 (eteplirsen). The FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet the criteria. [FR Notice]

International Regulatory and Compliance News

  • The European Medicines Agency (EMA) announced open access to clinical reports for new medicines for human use authorized in the European Union (EU). The EMA is providing access to the data in order to provide patients and healthcare professionals the ability to find out more information regarding the data underpinning approval of medicines they are taking or prescribing. [News Release] (EMA.europa.eu)
  • The International Medical Device Regulators Forum (IMDRF) announced the availability of three guidance documents for public consultation entitled, “Methodological Principles in the Use of International Medical Device Registry Data,” “IMDRF Terminologies for Categorized Adverse Event Reporting(AER): Terms, Terminology, Structure and Codes,” and “Software as a Medical Device (SaMD): Clinical Evaluation.” These documents are intended to provide a harmonized approach to the terminology and codes used in adverse event reporting, methodologies for analyzing registry data, and the clinical evaluation of SaMD, and all three public consultations are set to close on December 2, 2016. [Guidance] [Guidance] [Guidance] (Regulatory Focus)
  • Australia’s Therapeutic Goods Administration (TGA) proposed to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only if the conditions they target are classed as life-threatening or chronically debilitating. [TGA Notice] (Regulatory Focus)
  • The China Food and Drug Administration (CFDA) has released draft guidance on drug data management practices. The document is designed to help organizations involved in the development, production and distribution of pharmaceuticals to maintain accurate, timely and traceable data records. [CFDA Notice] (Regulatory Focus)

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      • Kim Trautman, Executive Vice President, Medical Device International Services, spoke at a lunch and learn webinar, “FDA Shared Inspections on the Horizon,” hosted by Xavier Health on October 20, 2016. Ms. Trautman is the foremost expert on where FDA is going with a shared inspection model and has led FDA efforts in the Medical Device Single Audit Program (MDSAP) development with other recognized regulatory authorities since its inception. While in FDA, she spearheaded this work with her international regulator colleagues by chairing the MDSAP Working Group for the International Medical Device Regulators Forum.[Registration]
      • Martin Lush, President, NSF Health Sciences Pharma Biotech Consulting has authored an article entitled, “Are You Facing a Complexity Crisis?” for the Journal. This article provides thoughtful realizations on complexity levels in the pharma industry, a brief questionnaire to assess some of the key complexity issues routinely experienced, and solutions to assist in moving from complex to simple in an organization’s structure. [Journal]
      • Mary C. Getz, Ph.D., Vice President, Quality, NSF Heath Sciences Medical Device Consulting has authored an article entitled, “Why FDA needs to have more enforcement over lab developed tests (LDTs).” This article provides background on in vitro diagnostics (IVDs) and lab-developed tests (LDTs) and discusses the reasons for why there should be FDA enforcement on LDTs. [Article]
      • Maxine Fritz, Executive Vice President, NSF Health Sciences Pharma Biotech Consulting has authored an article entitled, “Pharma Quality Systems – It’s All About the People” in the newest edition of the Pharma Journal. This article provides insights on understanding and accepting the commitment by management and resources as it relates to the cultural alignment necessary to improve and maintain quality systems through the remediation process. [Journal]
      • NSF Health Sciences Pharma Biotech Consulting announces its recent release of the Journal Issue 35 – “How Do You Really Know What’s Happening Out There?” This Journal includes a series of articles on how various job roles value and utilize KPIs, based on actual interviews, and our experts overall experience working with clients. [Newsletter] [Journal]
      • Martin Lush, President, NSF Health Sciences Pharma Biotech Consulting has authored an article entitled, “Human Error Prevention – Solutions & Answers,” for the Pulse. This article provides insights on evaluating the science of human error, and a methodology for investigatingincidents attributed to human error, identifying corrective and preventive actions (CAPAs) that focus on the underlying contributing factors. [Pulse]
      • NSF Health Sciences Medical Device Consulting will present trainings in Rotherham, UK on subjects including, the European Medical Device Directive & ISO 13485, Design Control, ISO 14971 Risk Management, Combination Product Regulations, and ISO 13485 Lead Auditor. These trainings are offered from April to November 2016. [Information and Registration]
      • New: Public Workshop. Substitutability of Generic Drugs: Perceptions and Reality. November 18, 2016. Discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. [FR Notice]