FDA Regulations for OTC Drugs


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Description of the topic:

The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail.  Labeling and advertising of OTC drugs will be covered.  Other requirements, including Registration, Drug Listing and Current Good Manufacturing Practice, will be reviewed.  Examples from recent Warning Letters and FDA Inspectional Observations (483s) will be used to show what not to do.

Background:

There are three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions.

 

Why should you attend?

Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs.  Knowledge of these rules and regulations is important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer

Areas Covered in the Session :

  • Rx versus OTC Drugs – Deciding which classification
  • How are OTC drugs regulated?
  • Labeling Rules
  •  CGMPs
  • Avoiding FDA Warning Letters

Who will benefit: 

  • Regulatory Affairs,
  • Labeling,
  • Quality
  • Advertising of OTC Drugs

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