Live web cast on Want to Sell OTC Drugs in the U.S.? … It’s Not as Hard as you Think! Understanding FDA’s Regulation of Over-the-Counter Drug Products (“OTC Drugs”) and Navigating the OTC Drug Monographs

Website https://www.compliance2go.com/product/?pid=CP2014-262 | Edit Freely

Category Biotechnology

Deadline: February 13, 2014 | Date: February 13, 2014

Venue/Country: houston, U.S.A

Updated: 2014-01-16 12:55:43 (GMT+9)

Call For Papers - CFP

Why you should attend

This webinar is intended to be a Practice-Based Online Workshop. It is designed to teach attendees the skills and requirements needed to design, develop and produce an OTC Drug Product for marketing and sale in the U.S.

Attendees will gain an understanding for the different options for producing and selling an OTC Drug Product in the United States. This includes exposure to the significant number of available Drug Monographs, selecting an appropriate Drug Monograph, navigating around a Drug Monograph, picking the right Active Ingredients and complying with FDA’s OTC Drug Labeling requirements.

Attendees will leave the workshop with a comprehensive understanding of FDA’s regulation of OTC Drugs and will be provided with strategic recommendations for mitigating the risk of enforcement action in the future.

Description of the topic

One of the children been playing in Poison Ivy again?

Have a Headache?

Wonder if there is a Drug Monograph for Nailbiting and Thumbsucking?

Back from lunch and have Heart Burn?

Suffer from Allergies?

Been stuck at home in bed with a Cough, Sore Throat, Nasal Congestion or a Fever that you just can’t shake?

Looking for a treatment for Diaper Rash?

Anyone who has ever has suffered from these or other occasional medical symptoms and conditions has likely relied upon an Over-the-Counter Drug Product or “OTC Drug” to feel better. Go into any CVS Retail Pharmacy, Wal-Mart, Meijer Grocery Story, Rite Aid Retail Pharmacy or Target in the US; and you are guaranteed to find store shelves lined with hundreds or even thousands of different OTC Drug products.

Market studies suggest that there are currently over 300,000 OTC Drugs being marketed and sold in the U.S. today and that number is growing daily. This amounts to almost 60% of the total U.S. drug market (by purchases) and this number is expected to grow in the future. Based on these predictions alone, this is a profitable market and growth potential that drug and health product companies cannot afford to ignore.

If you can cook and follow a recipe; then you can make an OTC Drug Product with access to the necessary resources and an appropriate facility.

Some of the most recognized OTC drug products include ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medicines and topical pain relievers. Available without a prescription and bought right off the store shelf, OTC drugs are safe and effective when properly labeled and used as intended.

Most OTC drugs available today are OTC Monograph Drug Products. A very, very small percentage of those products on the market today are actually the subject of an approved New Drug Application or NDA.

Significant industry growth can also be seen in the area of FDA’s permitted Rx-to-OTC Switch Program which allows companies with FDA approved Prescription (Rx) drugs to transition those products into the OTC drug space. Examples includes Prilosec and Pepcid AC. The OTC Switch Program is becoming increasingly more popular as pharmaceutical companies look for strategic ways to extend the overall Product Life Cycle of their hugely profitable Rx drug products.

Areas Covered In the Seminar:

This online workshop will provide attendees with a comprehensive review and understanding of the process for designing, developing, manufacturing and selling an OTC Drug Product in the U.S. For purposes of regulatory compliance, the workshop will also focus on FDA’s regulatory requirement covering OTC drug products; and offer strategic recommendations for not only success but also for mitigating the risk of FDA enforcement risk and general liability.

Some of the topics to be covered during this online workshop will include:

FDA’s requirements for marketing and selling an OTC drug product in the U.S.

Methods for determining whether a drug product can be marketed and sold as an OTC drug

The regulatory pathways for commercialization of an OTC drug product

The OTC Monograph process and Understanding how to Use Them

FDA’s permitted Rx-to-OTC Switch Process

How to properly label and market an OTC drug product, and

Strategies for mitigating regulatory enforcement risks and liability.

Who will benefit:

Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Investment Analysts, Venture Capitalists.

OTC, Consumer Product and Drug Companies; Start-ups, Foreign Drug Manufacturers, Importers; Food and Dietary Supplement manufacturers and distributors exploring new potential product sectors

Financial analysts and investors watching the pharmaceutical, OTC, consumer product, life sciences and biotech industries

Link to FDA’s OTC Monograph Page:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/default.htm

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance