FDA BRIEF: Week of May 15, 2017

fda

Dr. Gottlieb’s First Remarks to FDA Staff

Remarks by Commissioner Scott Gottlieb, M.D. at FDA All Hands Meeting

  • People’s lives depend on what FDA does
  • Great promise with scientific advances to make regulatory process more modern and efficient
  • Immediate challenge – opioid abuse and FDA’s role in minimizing use
  • Also help address challenge of prohibitive drug pricing – even though FDA does not have a direct role
  • Overall, need for risk-based, patient-centric, science-based approach and maintaining  gold standard for regulatory science and independent, science-led decision-making

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Safe Use blog image

Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone

By: John J. Whyte, M.D., M.P.H. , Director of Professional Affairs and Stakeholder Engagement, CDER 

Harm from medications also may come from known risks that could have been prevented

  • 1.5 million preventable adverse drug events occur each year
  • Prescribers and other providers struggle with intricacies of health care system
  • Patients have difficulty following detailed directions
  • Manufacturers need careful packaging and labeling to avoid confusion

Reducing preventable harm from medications is a big part of FDA’s mission

  • Hosting a one-day public meeting  “Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.”
  • Meeting with all stakeholders to discuss sources of preventable harm from drugs in outpatient setting

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Accreditation Scheme for Conformity Assessment Pilot Program

Voluntary consensus standards establish safety & performance criteria for medical device design and manufacturing

  • Support claims of safety and quality in FDA premarket review
  • Sponsors include a `Declaration of Conformity” to attest to standards

Challenge

  • Appropriate use of FDA recognized consensus standards not consistently applied
  • Require substantial specialized knowledge to interpret and apply correctly

Addressing Challenge

  • FDA and Industry to establish an FDA Accreditation Scheme for Conformity
    Assessment (ASCA) Program
  • Recognize accredited testing laboratories that evaluate medical devices according to FDA standards
  • Ease industry regulatory burden by allowing them to use recognized accredited test laboratories to ensure accurate conformance with the consensus standard
  • FDA requesting comments on proposal by June 30

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Family walking on the beach. Mom says: Boys! You have sunscreen on now, but don't forget you need to reapply every 2 hours while we're at the beach. If you're in and out of the water, we'll need to reapply more often.  Boys say: Ok mom!

Sunscreen: FDA Regulated Product

Sunscreen is an FDA-regulated product, for protection from sunburn, skin cancer, early skin aging and other risks of sun overexposure 

Sun protection factor (SPF) in Label

  • Indicates level of sunburn protection: Amount on UVB and UVA radiation to cause sunburn with sunscreen vs without
  • Higher SPF values (up to 50) provide greater sunburn protection
  • “Broad Spectrum SPF [value]” in label indicate protection from both

Other Label Information  

  • List of acceptable active/inactive ingredients
  • Expiration dates based on stability testing
  • Ex-US products may not have same label standards as FDA

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Image credits: FDA

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