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FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products

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e-Patient Connections
e-Patient Connections

Presentation by Barbara Chong, FDA

Health & Medicine
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The following presentation was delivered at e-Patient Connections 2010 Join the community at http://KruResearch.com/subscribe
FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products Barbara Chong, Pharm.D., BCPS Team Leader, Training and Support Division of Drug Marketing, Advertising, and Communications Center for Drug Evaluation and Research Food and Drug Administration
DDMAC’s Mission ,[object Object],[object Object],[object Object]
21 CFR 202.1 ,[object Object],[object Object],[object Object],[object Object]
Professional Review Group I Leader Andrew Haffer (acting) Neurology (Quynh-Van Tran) Oncology Biologics (Carole Broadnax) Reproductive, Urology (Janice Maniwang) Psychiatry (Jessica Clerk Derenick) Professional Review Group II Leader Karen Rulli (acting) Oncology Drugs: Solid tumors (Keith Olin) Oncology Drugs: Hematologic Cancers (Adam George, Nisha Patel) Hematology, Medical Imaging (James Dvorsky) Director’s Office Director, Thomas Abrams Deputy Director, vacancy Associate Director, Mark Askine Associate Director of Operations, Marci Kiester Management Advisor, Catherine Gray Management Advisor, Robert Dean Special Assistant, Jean-Ah Kang Program Specialist, Becki Vogt Professional Review Group III Leader Lisa Hubbard Pulmonary, Allergy, Rheumatology (Roberta Szydlo) Analgesics, Anesthetics (Mathilda Fienkeng) Metabolism and Endocrinology (Samuel Skariah) Gastroenterology (Kathleen Klemm) Professional Review Group IV Leader Sheila Ryan Cardiovascular and Renal (Emily Baker) Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Christine Corser) Antivirals (Lynn Panholzer) Dermatology, Dental (Vacancy) The Division of Drug Marketing, Advertising, and Communications Direct- To-Consumer Review Group I Leader Michael Sauers Reproductive (Carrie Newcomer) Psychiatry (Susannah Hubert) Urology (Osteo, Other), Antivirals, Special Pathogens, Transplant (Michelle Safarik) Dermatology, Dental (Sheetal Patel) Direct- To-Consumer Review Group II Leader Aline Moukhtara (acting) Neurology (Sharon Watson, Beth Carr) Pulmonary, Allergy (Robyn Tyler) Urology (Vacancy) Research Team (Kathryn Aikin, Amie O’Donoghue, Helen Sullivan) Regulatory Counsel Team Leader, Sangeeta Vaswani Regulatory Counsel, Marissa Chaet Brykman Regulatory Counsel, Julie Burger Regulatory Counsel, Bryant Godfrey Regulatory Counsel, Ernest Voyard IT Specialist, Michael Wade Evidence Review & Division Support, Elaine Cunningham Regulatory Project Manager, Wayne Amchin Training & Support, Barbara Chong TIA, Janet Daly TIA, Sharon Smith Direct- To-Consumer Review Group IV Leader Amy Toscano (acting) Cardiovascular and Renal (Zarna Patel) Oncology Drugs ( Stephanie Victor) Hematology, Medical Imaging, Anti-Infectives, Ophthalmology (JuWon Lee) (Vacancy) Direct- To-Consumer Review Group III Leader Shefali Doshi (acting) Anesthetics, Analgesics, Rheumatology (Twyla Thompson) Gastroenterology (Cindy Collins) Oncology Biologics (Vacancy) Metabolism and Endocrinology (Kendra Jones)
Final Promotional Pieces Submitted on Form FDA 2253 (1997 – 8/1/10)
DDMAC Enforcement Letters (2002 – 8/31/10)
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Part 15 Hearing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Part 15 Hearing
Part 15 Hearing
Part 15 Comments ,[object Object],[object Object],[object Object]
Part 15 Comments
Part 15 Comments
Part 15 Total
Part 15 Total
Guidance Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Future Direction ,[object Object],[object Object]
How Does DDMAC Regulate? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Advice to Industry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Submission Requirement ,[object Object],[object Object],[object Object]
Enforcement Actions ,[object Object],[object Object],[object Object],[object Object],[object Object]
DDMAC Contact Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
DDMAC Contact Information ,[object Object],[object Object],[object Object],[object Object],[object Object]

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FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products

  • 1. The following presentation was delivered at e-Patient Connections 2010 Join the community at http://KruResearch.com/subscribe
  • 2. FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products Barbara Chong, Pharm.D., BCPS Team Leader, Training and Support Division of Drug Marketing, Advertising, and Communications Center for Drug Evaluation and Research Food and Drug Administration
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  • 5. Professional Review Group I Leader Andrew Haffer (acting) Neurology (Quynh-Van Tran) Oncology Biologics (Carole Broadnax) Reproductive, Urology (Janice Maniwang) Psychiatry (Jessica Clerk Derenick) Professional Review Group II Leader Karen Rulli (acting) Oncology Drugs: Solid tumors (Keith Olin) Oncology Drugs: Hematologic Cancers (Adam George, Nisha Patel) Hematology, Medical Imaging (James Dvorsky) Director’s Office Director, Thomas Abrams Deputy Director, vacancy Associate Director, Mark Askine Associate Director of Operations, Marci Kiester Management Advisor, Catherine Gray Management Advisor, Robert Dean Special Assistant, Jean-Ah Kang Program Specialist, Becki Vogt Professional Review Group III Leader Lisa Hubbard Pulmonary, Allergy, Rheumatology (Roberta Szydlo) Analgesics, Anesthetics (Mathilda Fienkeng) Metabolism and Endocrinology (Samuel Skariah) Gastroenterology (Kathleen Klemm) Professional Review Group IV Leader Sheila Ryan Cardiovascular and Renal (Emily Baker) Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Christine Corser) Antivirals (Lynn Panholzer) Dermatology, Dental (Vacancy) The Division of Drug Marketing, Advertising, and Communications Direct- To-Consumer Review Group I Leader Michael Sauers Reproductive (Carrie Newcomer) Psychiatry (Susannah Hubert) Urology (Osteo, Other), Antivirals, Special Pathogens, Transplant (Michelle Safarik) Dermatology, Dental (Sheetal Patel) Direct- To-Consumer Review Group II Leader Aline Moukhtara (acting) Neurology (Sharon Watson, Beth Carr) Pulmonary, Allergy (Robyn Tyler) Urology (Vacancy) Research Team (Kathryn Aikin, Amie O’Donoghue, Helen Sullivan) Regulatory Counsel Team Leader, Sangeeta Vaswani Regulatory Counsel, Marissa Chaet Brykman Regulatory Counsel, Julie Burger Regulatory Counsel, Bryant Godfrey Regulatory Counsel, Ernest Voyard IT Specialist, Michael Wade Evidence Review & Division Support, Elaine Cunningham Regulatory Project Manager, Wayne Amchin Training & Support, Barbara Chong TIA, Janet Daly TIA, Sharon Smith Direct- To-Consumer Review Group IV Leader Amy Toscano (acting) Cardiovascular and Renal (Zarna Patel) Oncology Drugs ( Stephanie Victor) Hematology, Medical Imaging, Anti-Infectives, Ophthalmology (JuWon Lee) (Vacancy) Direct- To-Consumer Review Group III Leader Shefali Doshi (acting) Anesthetics, Analgesics, Rheumatology (Twyla Thompson) Gastroenterology (Cindy Collins) Oncology Biologics (Vacancy) Metabolism and Endocrinology (Kendra Jones)
  • 6. Final Promotional Pieces Submitted on Form FDA 2253 (1997 – 8/1/10)
  • 7. DDMAC Enforcement Letters (2002 – 8/31/10)
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