FDA Rules and Regulations

By Joe Swisher


In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used. The FDA see many ads at about the same time the public sees them. Many drug companies voluntarily seek advice from us before they release TV ads. However, if they (The FDA) believe that an ad violates the law, they send a letter to the drug company asking that the ads be stopped right away.


The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application for FDA’s review prior to testing in humans.