FDA BRIEF: Week of April 3, 2017


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Future of Drug Development

Future Drivers:

  • International regulatory convergence
  • Advanced manufacturing
  • Rise of biosimilars
  • New science and technology
  • Digital revolution
  • Drug costs

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Irritable_Bowel_Syndrome
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Irritable Bowel Syndrome Treatments Aren’t One-Size-Fits-All

Irritable bowel syndrome (IBS) often misunderstood and underdiagnosed condition

  • Affects about 15.3 million people in US
  • Difficult to diagnose in children- 14% of high school students and 6% of middle school students have IBS
  • No approved medications to cure IBS
  • No approved medications for treating IBS symptoms in children
  • Treatments vary from patient to patient and include changes in diet, nutrition, exercise
  • Drugs are a last option

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A girl giving her friend a manicure

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Cosmetics vs Drugs and Medical Devices: Q&A

Are all “personal care products” regulated as cosmetics?

  • Products intended to cleanse or beautify are generally regulated as cosmetics
  • Products intended to treat or prevent disease, or affect the structure or function of the body, are drugs : dandruff or acne products, sunscreen products, antiperspirants, and diaper ointments
  • Some are both cosmetics and drugsanti-dandruff shampoos and antiperspirant-deodorants, moisturizers and makeup with SPF
  • Some may belong to other categories: medical devices (hair removal and microdermabrasion devices), dietary supplements (vitamin, mineral tablets,  capsules), consumer products (manicure sets).

Are some drugs or “cosmeceuticals”?

  • Law does not recognize any such category

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