FDA BRIEF: Week of April 3, 2017
Future of Drug Development
- International regulatory convergence
- Advanced manufacturing
- Rise of biosimilars
- New science and technology
- Digital revolution
- Drug costs
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
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 drugs: anti-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