FDA Regulatory and Compliance News

  • FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a guidance for industry and FDA staff entitled, “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” This guidance applies to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes, and provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments. [Guidance] (FDA.gov)
  • FDA announced the issuance of two Emergency Use Authorizations (EUAs) for in vitro diagnostic devices (IVDs) for detection of the Zika virus in response to the outbreak in the Americas. These IVDs are manufactured by Vela Diagnotics USA, Inc. and ARUP Laboratories. [FR Notice]
  • FDA announced the availability of a guidance for industry and FDA staff entitled, “Collection of Race and Ethnicity Data in Clinical Trials.” This guidance is intended to provide FDA expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA-regulated medical products conducted in the United States and abroad. [Guidance] (FDA.gov)

FDA posted a blog entitled, “Key Facts about ‘Abuse-Deterrent’ Opioids.” In the post, the Agency discussed its support of manufacturers that develop abuse-deterrent opioid drugs, encouraged the development of abuse-deterrent generic drugs, reaffirmed their opioid action plan issued in February to reduce opioid misuse and abuse and help fund the development of assessment tools to evaluate packaging, storage, delivery, disposal solutions, and product formulations to support that plan. [FDA Voice] (FDA.gov)

FDA announced the approval of St. Jude Medical Inc.’s Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart and then traveled to the brain. The safety and efficacy of the device was demonstrated in a randomized study that evaluated 499 participants aged 18 to 60 years old who were treated with the Amplatzer PFO Occluder plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications alone. [News Release] (FDA.gov)

FDA announced the availability of a guidance for industry and FDA staff entitled, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.” This guidance addresses the inclusion of a boxed warning and patient decision checklist in the product labeling for permanent hysteroscopically-placed tubal implants intended for female sterilization and the content and format of those materials, and the guidance applies to all devices of this type, regardless of the insert material composition, location of intended implantation, or exact method of delivery. [Guidance] [FR Notice]

FDA announced the availability of a report on the performance of drug and biologics firms in conducting postmarketing requirements and commitments. The report provides the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct, and the Agency also announced a supplemental report entitled, “Supplementary Report: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) (FY 2013 and FY 2014),” containing additional information and analyses on the status of PMRs and PMCs as of September 30, 2013, and September 30, 2014. [FR Notice and Report] [Supplementary Report]

International Regulatory and Compliance News

  • Australia’s TGA announced a new consultations for public comment that would creat new priority review and provisional approval pathways. The priority review pathway will involve faster reviews of prescription drugs in certain circumstances, potentially allowing consumers with serious and life-threatening conditions to gain access to these medicines more quickly, and the provisional approval pathway will provide earlier access to certain promising new medicines that do not yet have a full dossier of clinical data but have solid early data on efficacy and safety. [TGA Consultation] (Regulatory Focus)

Staff News

  • NSF International appoints Gunter Frey as Executive Director, Quality Systems, for NSF Health Sciences Medical Devices. Mr. Frey brings over 25 years of experience in industry, formerly holding regulatory, quality systems, and compliance positions at Philips and GE Healthcare. In his role, he will serve as a Quality Systems expert, offering a wide range of consultation and training services to NSF clients, including system-based gap analyses, Quality Systems development and implementation, and remediation and compliance support in response to enforcement action.
  • 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., Director, Quality Systems 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 investigat ingincidents 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: Science Board to the Food and Drug Administration. November 15, 2016. Hear about: (1) The Center for Biologics Evaluation and Research’s strategic goals for regulatory science; (2) a progress update on FDA’s Opioid Action Plan and the Bovine Heparin Initiative; (3) a response from the Office of Scientific Professional Development to the Science Board’s report on the Commissioner’s Fellowship Program; (4) a report from the Scientific Engagements Subcommittee; (5) and a report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee. [FR Notice]

Next Week

  • Risk Communication Advisory Committee. November 7, 2016. Discuss recommendations on FDA’s draft Strategic Plan for Risk Communication and Health Literacy clarifying Agency communications on benefits and risks of FDA-regulated products to target audiences more effectively, and so promote better informed decision making. [FR Notice]
  • Public Workshop. CDC/FDA/NLM/ ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data. November 8, 2016. Discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results. [FR Notice]
  • Clinical Investigator Training Course. November 7-9, 2016. Provide clinical investigators, such as clinicians, nurses, pharmacists, and other health care providers involved in conducting clinical trials, with expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. [FR Notice]
  • Microbiology Devices Panel of the Medical Devices Advisory Committee. November 9-10, 2016. Discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)), and discuss and make recommendations to FDA regarding how FDA might handle a future premarket notification (510(k)) submission for a Procalcitonin (PCT) test. [FR Notice]

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