News & Views: CDRH women health plan, ASCA, ALS guidance, Patient engagement, Limited Imodium packaging, Improving naloxone access, Premarket Tobacco Product Applications, Project Orbis

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CDRH: Health of Women Strategic Plan

  • Explores unique issues related to the performance of medical devices in women
  • Improves analysis and communication of sex- and gender-specific data to better assure the safe and effective use of medical devices
  • Develops and implements health science programs, strategies and initiatives focused on women’s health issues across CDRH

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The Accreditation Scheme for  Conformity Assessment (ASCA): Pilot Program

Under ASCA Pilot’s conformity assessment scheme, recognized accreditation bodies accredit testing laboratories for the competence of testing and calibration laboratories

  • ASCA-accredited testing laboratories may determine conformance of device with eligible standards
  • Provide declaration of conformity  to support  premarket submission

Scope

  • Development of the ASCA pilot
  • Conformity assessment resources leveraged in ASCA Pilot
  • Roles and Responsibilities: Accreditation bodies, Testing laboratories, Manufacturers, FDA staff
  • Selected Device Standards
  • Accreditation body and Testing Laboratory Participation

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Amyotrophic Lateral Sclerosis Guidance

ALS is progressive neurodegenerative disease that primarily affects motor neurons in cerebral motor cortex, brainstem, spinal cord, leading to loss of voluntary movement

  • Guidance focuses on specific clinical drug development and trial design issues that are unique to the study of ALS

Considerations

  • Early Phase Clinical Development, Population,  Effectiveness and Safety Considerations.
  • Specific Effectiveness Trial : Trial design, effectiveness endpoints,  timing of assessments, statistical considerations., prognostic factors,  integrated assessment of function and survival, Accelerated Approval considerations, Benefit-Risk considerations.

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Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

FDA values experience and perspectives of patients and their family caregivers. Draft guidance scope:

  • Use patient engagement to elicit experience, perspectives from patient advisors to improve design and conduct of medical device clinical investigations
  • Benefits of engaging with patient advisors
  • Patient engagement activities not considered by FDA to constitute research
  • Collecting and submitting patient engagement information

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Limited packaging for loperamide (Imodium) to encourage safe use

Reports of serious heart problems and deaths with much higher than the recommended doses of loperamide

  • Primarily among people intentionally misusing or abusing the product

To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide

  • Use blister packs or other single dose packaging and to limit the number of doses in a package

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Continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

Addressing opioid overdose continues to be one of the most urgent public health priorities

  • Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths
  • Three FDA-approved forms of naloxone – injectable, auto-injector and nasal spray – require a prescription, which can be a barrier

Steps to improve access to naloxone (Narcan)

  • Pharmacists given direct authority to prescribe and sell naloxone to consumers
  • Community distribution and use by individuals with or without medical training
  • Approveal of first generic version of Narcan
  • Encouraging development of OTC naloxone products.

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Proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products

Premarket tobacco product applications (PMTAs) for oversight of e-cigarettes and other tobacco products. Provide sufficient information on 

  • Physical aspects of a tobacco product
  • Potential public health benefits and harms
  • Also review tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled
  • Establish requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products

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FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies

Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), provides  framework for concurrent submission and review of oncology products among international partners

  • May allow cancer patients receive earlier access to drkugs
  • Greater uniformity of new global standards of treatment leading to the optimal design of  global clinical trials

First Project Orbis action in conjunction with the Australian Therapeutic Goods Administration and Health Canada

  • Accelerated approval to Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for treatment of advanced endometrial carcinoma
  • Also used ‘Real-Time Oncology Review’ (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application

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Image credits: FDA, CDC

News & Views: AEDs, Office on New Drugs reorganization, New digital health policies, Office of Women’s Health, THC vapes warning

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Check Your AED: Is it FDA Approved?

Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat sudden cardiac arrest,

  • Public access AEDs used by laypeople who have received minimal training
  • Professional use AEDs  used by first responders who receive additional AED training

Premarket approval (PMA) now required new and existing AEDs and necessary AED accessories batteries, pad electrodes, adapters and hardware keys for pediatric use)- deadline Feb 3, 2020

  • To ensure the quality and reliability
  • Needs sufficient valid scientific evidence to reasonably assure the device is safe and effective
  • Requires manufacturers to receive FDA approval before initiating design, manufacturing, or labeling changes to the device, imposes certain other annual reporting requirements.

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Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

To modernize the New Drugs Regulatory Program – a reorganization of the New Drugs Regulatory Program

Restructuring of the Office of New Drugs (OND) and corresponding changes in the Office of Translational Sciences (OTS) and Office of Pharmaceutical Quality (OPQ)

  • Create offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise
  • Enable greater efficiency, better understand the diseases, enhance scientific leadership

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New steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Guidances to continue to encourage innovative approaches to the development of digital health tools and advanced FDA oversight 

Clinical Decision Support Software, (revision)

  • Patients, families and health care professionals increasingly embracing digital health technologies to inform everyday decisions
  • Encourage developers to create, adapt and expand functionalities of software to support providers in diagnosing and treating diseases, while ensuring  no  unacceptable risk to patient
  • Focus our regulatory oversight on CDS functions intended to help health care professionals and patients inform their clinical management for serious or critical conditions- no independent evaluation of the basis of software’s recommendations

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

  • Types of software that are no longer considered medical devices under the amended definition of device
  • Mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope FDA’s regulation

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Critical Focus on Women’s Health

Office of Women’s Health established in 1994  to advance health of women through science, policy, education, outreach, and inclusion of women in clinical trials

  • Investing in Women’s Health Through Engagement and Education 
  • Fostering Scientific Research and Filling Knowledge Gaps
  • Advancing Medical Therapies that Meet Women’s Needs

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FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

FDA strengthening warning to consumers to STOP using vaping products containing THC

  • More than 1,000 reports of lung injuries- including some resulting in deaths-following the use of vaping products
  • Most of the patients reported using THC-containing products, suggesting THC vaping products play a role in the outbreak

FDA Actions

  • Working closely with federal and state partners to identify the products or substances that may be causing the illnesses
  • FDA’s Forensic Chemistry Center using state-of-the-art technology to analyze hundreds of samples for the presence of a broad range of chemicals

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Image credit: FDA