The FDA and drug marketing

discussing the rules and regulations

How effective are these rules?

The rules for the FDA are very effective because they cannot be false leading in any way particular, and they must reveal material facts about the product being promoted.

warnings

  • warnings are sent out to inform the products that they may be doing illegal activities and informs them of the rules and regulations.
  • They are usually sent out every month.
  • Evidence shows that a firm, product, and/or individual is in violation of the law or regulations and that failure to achieve adequate and prompt correction may result in agency consideration of an enforcement action;
  • The violation(s) are determined to be of regulatory significance, and the issuance of a Warning Letter is appropriate and consistent with agency policy, as described in Compliance Policy Guides or elsewhere; and,
  • There is a reasonable expectation that the responsible firm and persons will take prompt corrective action.

Rules and regulations

  • the FDA has rules they have to follow in order to be able to sell their product.
  • If they are not approved they can not be sold.
  • FDA judges them on how safe they are and how they will effect their consumers.
  • non FDA approved products can be life threatening.

Unapproved Prescription drugs

The FDA usually requires that the drugs in the U.S be shown to be both safe and effective prior to marketing. The evidence based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are safe. Most doctors suggest to do your research before using certain drugs.