Over the Counter Drugs: Classification, Approval and Compliance, a Practical Review

8:30–10:00 am

OTC Drugs in the US

Objectives:
Understand what OTC drugs are, their regulation in the US, and their home in the current structure of the FDA

Speaker(s):
M. Scott Furness, PhD, director, Division of Nonprescription Regulation Development (DNRD), Office of Drug Evaluation IV (ODE-IV), Office of New Drugs (OND), CDER, FDA
David Schifkovitz, vice president, regulatory affairs, CHRD, GlaxoSmithKline Consumer Healthcare
Marcy Sussman, assistant director, regulatory affairs, GlaxoSmithKline

10:30 am–12:00 pm

OTC vs. Botanicals & Dietary Supplements

Objective:
Understand the registration and compliance differences between OTC drugs, botanicals and dietary supplements

Speaker:
Robert Schiff, PhD, RAC, CQA, FRAPS, CEO & president, Schiff & Company, Inc.

1:00–1:30 pm

Registration of OTC Drugs

Objective:
Analyze what needs to be registered for an OTC drug, how often and how to navigate FDA’s electronic filing system

Speaker:
Gary Saner, senior manager, Information Solutions - Life Sciences, Reed Technology and Information Services Inc.

1:30–2:30 pm

Compiling a Drug Facts Label

Objective:
Take part in a hands-on demonstration of the creation of a compliant Drug Facts label

Speaker:
Holly Young, president, H + Y Regulatory Graphics Consultants, LLC

3:00–4:30 pm

Time and Extent Applications (TEA)

Objectives:
Understand the background and submission of a TEA and how it is approved. Included is a tutorial on how to proceed through a submission.

4:30–5:00 pm

Panel Q/A