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New required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking

Science-based approach to develop and evaluate the new proposed cigarette health warnings

  • Focus on serious health risks – such as bladder cancer, diabetes, erectile dysfunction and conditions that can cause blindness

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CaptureFederal and CDC collaboration to investigate respiratory illnesses reported after use of e-cigarette products

FDA and CDC collaborating to investigate incidents of severe respiratory disease associated with use of e-cigarette products

  • Updating the number of potential cases of respiratory illnesses after use of e-cigarette products
  • Sharing more details about CDC and FDA work
  • Providing public and health partners across the country with information to help mitigate risk of additional incidents

More information needed to better understand relationship between specific products and reported illnesses

  • THC and cannabinoids use reported in many cases
  • e-cigarette products should not be used by youth, young adults, pregnant women, and adults who do not currently use tobacco products

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Capture.JPGTransition to Duodenoscopes with Innovative Designs to Enhance Safety

  • Duodenoscopes used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year
  • Have complex designs with reusable hard-to-clean components
  • Failure to correctly reprocess duodenoscope could result in patient-to-patient disease transmission
  • Recommendation to use duodenoscopes with innovative device designs that make reprocessing easier, more effective, or unnecessary. (e.g. Fujifilm Corporation, Duodenoscope model ED-580XT, Pentax Medical, Duodenoscope model ED34-i10T)

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Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

In premarket decision-making for devices, there exists some uncertainty around benefits and risks – type, magnitude, duration, frequency, other aspects

Appropriate uncertainty in a benefit-risk determination would depend on totality of information covering several factors

  • Extent of probable benefits of the device – magnitude, probability, duration, frequency
  • Extent of probable risks of the device- severity, type, number, rates, probability,  duration
  • Extent of uncertainty of benefit-risk profile of  precedent devices
  • Patients’ perspective on appropriate uncertainty
  • Extent of the public health need
  • Feasibility of generating extensive premarket clinical evidence
  • Ability to reduce or resolve remaining uncertainty postmarket
  • Effectiveness of mitigations, such as labeling, and other tools
  • Type of decision being made (e.g., HDE vs PMA)
  • Probable benefits of earlier patient access to the device

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Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

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Male Breast Cancer: Developing Drugs for Treatment

Breast cancer is rare in males (<0.1%),  diagnosed at an older age, with more advanced stage of disease, and more likely to have lymph node involvement 

  • Eligibility criteria for clinical trials of breast cancer drugs should allow for inclusion of both males and females
  • May be possible to extrapolate findings to male patients where no difference in efficacy or safety between males and females is anticipated

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Delivering Promising New Medicines Without Sacrificing Safety and Efficacy

Congress has established five programs to expedite patient access to drugs that treat serious or life-threatening conditions while maintaining FDA’s gold standard of safety and efficacy

To assist drug development

  • Fast Track designation:  Drug is intended to treat a serious disease and that laboratory, animal model, or human data show promise
  • Breakthrough Therapy designation:  Preliminary clinical evidence indicates that  drug may demonstrate substantial improvement over available therapy
  • Regenerative Medicine Advanced Therapy designation (RMAT): Preliminary clinical evidence indicates regenerative medicine therapy has potential to address unmet medical needs for such condition

To expedite FDA review timelines: 

  • Priority Review designation FDA aims to take action on a marketing application within six months, compared to 10 months under standard review. Only granted if  data submitted in the marketing application appear to show a significant improvement in safety or effectiveness for a serious condition

Different route for expediting:

  • Accelerated Approval: Approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit

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Image credit: FDA