OTC Drug FDA Regulation

Website https://worldcomplianceseminars.com/webinardetails/454 | Edit Freely

Category

Deadline: August 02, 2018 | Date: August 02, 2018

Venue/Country: Online, U.S.A

Updated: 2018-07-13 21:15:07 (GMT+9)

Call For Papers - CFP

Time: 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Description

The FDA and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The FDA is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 4 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.

Areas Covered

• Gain an understanding of how OTC drug products are regulated in the U.S.

• Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.

• Understand the difference between the various pathways for commercializing an OTC drug product.

• Learn how to identify and successfully navigate an OTC Drug Monograph.

• Know when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.

• Know the required elements of a compliant OTC Drug Label.

• Understand strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.

• Learn the Rx-to-OTC Switch Process.

• Review and evaluate several of FDA’s current OTC Monographs and Warning Letters

Who will Benefit

• Regulatory affairs managers, directors and associates

• Compliance specialists

• Marketing managers

• Quality professionals

• Document control specialists

• Record retention specialists

Speaker Profile

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

Price: $199 One Dial-in One Attendee | Corporate Live Recorded $249 One Dial In - Max 10 attendees |Group $399 Multiple locations upto 5 dial in | Recorded $209