Transition of FDA Leadership: Dr. Ned Sharpless as Acting Commissioner

Farewell to Commissioner Gottlieb

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FDA and CBP bolster collaboration to protect public health and safety

FDA and CBP agreement to maximize inspection and detection capabilities

  • Prevent illegal and harmful products entering International Mail Facilities and Ports of Entry
  • Sharing of FDA’s advanced screening technology to identify trends in future entries
  • Shared space and increased scientific presence at high-risk/high-volume facilities

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Continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Products containing cannabis or cannabis derivatives marketed as human drugs, dietary supplements, conventional foods, animal foods/drugs, cosmetics

  • Public hearing on May 31 to share experiences and challenges and product safety
  • Formation of high-level internal agency working group on potential pathways for dietary supplements to be lawfully marketed
  • Webpage on FDA’s requirements for these products
  • Issuance of multiple warning letters to companies marketing CBD products with  unfounded claims aimed at vulnerable populations

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Treatment strategies for nicotine addiction and teen use of e-cigarettes

To address troubling epidemic of youth e-cigarette use

  • Youth Tobacco Prevention Plan to ensure no tobacco products marketed to kids
  • Enforcement actions on illegal sales
  • Public education campaigns to warn youth
  • Advanced new policies aimed at preventing youth access to flavored tobacco products, including e-cigarettes and cigars
  • Workshop to examine science and treatment strategies for youth tobacco cessation

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Capture.JPGA Risk-Based Approach to Monitoring of Clinical Investigations

Scope: identifying critical data and processes necessary for human subject protection,investigation integrity, risk assessment, specific monitoring plan

  • Tailor monitoring plans to needs of investigation
  • Factors to consider in developing monitoring plan
  • Examples of monitoring methods and techniques
  • Risk-based monitoring important tool to identify and address issue

Monitoring Approach: include information regarding identified risks and how monitoring methods will address those risks

Monitoring Plan Content: A detailed list

Follow-Up and Communication of Monitoring Results: Significant issues identified through monitoring with appropriate Corrective and Preventive Actions

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Medical CounterMeasures (MCMs) update

FDA responsible for safety and effectiveness of MCMs—drugs, therapeutic biologics,vaccines, devices, such as diagnostic tests

  • Smallpox preparedness: TPOXX for treatment of smallpox
  • Chemical nerve agent preparedness: Atropine autoinjector for treatment of poisoning by susceptible organophosphorous nerve agents and Seizalam (midazolam intramuscular injection) for the treatment of status epilepticus
  • Radiological/nuclear emergency preparedness: New indication for Leukine (sargramostim) to increase survival in acute exposure to radiation
  • Viral encephalitis preparedness: IXIARO Japanese Encephalitis Virus Vaccine
  • Zika protection: COBAS Zika to screen Zika virus in blood donations
  • Pandemic influenza preparedness: FLUARIX Influenza Virus Vaccine

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Finalized List of Accessories Suitable for Class I

For  accessory to be eligible for class I distinct from another device if the accessory

  • is not for use in supporting or sustaining human life
  • does not represent potential unreasonable risk of illness or injury
  • general controls sufficient for reasonable assurance of safety and effectiveness
§ 876.1080 Gastroenterology-urology accessories to a biopsy instrument
§ 876.3500 Penile implant surgical accessories
§ 876.4630 Ureteral stent accessories
§ 876.5012 Biliary stent, drain, and dilator accessories
§ 876.5100 Suprapubic catheter accessories
§ 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories
§ 878.5080 Air-handling apparatus accessory
§ 886.4355 Corneal inlay inserter handle

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CaptureFDA OMH has a new name: FDA Office of Minority Health and Health Equity (OMHHE)

Reorganization reflects commitment to modernizing structure to:

  • Advance mission to protect and promote public health
  • Meet challenges of rapid innovation across industries regulated by FDA
  • Better captures breadth of portfolio and continue to address needs of racial and ethnic minority populations and underserved communities

New organization chart


Image credit: FDA