Understanding the Regulatory Requirements for the Over the Counter (OTC) Drugs in the US

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Category Houston

Deadline: May 24, 2016 | Date: May 24, 2016

Venue/Country: Online, U.S.A

Updated: 2016-05-06 15:05:30 (GMT+9)

Call For Papers - CFP

The US FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.

To introduce OTC (nonprescription) drug products into the U.S., it is important to accurately understand regulatory requirements applicable for the OTC products including regulatory pathways.

This webinar is intended to help you better understand how OTC nonprescription drugs are developed and brought into the US market.

The speaker will walk you through the regulatory requirements applicable to bring OTC drugs to the market.

Areas To Be Covered in this Seminar:

Laws and Regulations Governing OTC Drugs

Definitions

Key Considerations for OTC Drug Developments

Regulatory Pathways for OTC Drugs

Regulatory Requirements

FDA Review and Regulatory action

OTC Monographs

Critical Considerations

Understanding FDA and FTC Jurisdictions

Recent FDA Approvals of OTC Drugs

PASS-IT Recommendations

Who will benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

R&D

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA Drug Review and Approval Processes

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance