The process that a drug undergoes before it makes its way into your medicine cabinet is long and often complex. In addition to providing the FDA, or Food and Drug Administration, with proof that a drug is safe, drug manufacturers must also provide the organization with proof that the drug is effective. The process begins with an application for approval. Also, drug approval varies with the type of medication being offered, whether it is a prescription drug or an over-the-counter drug.

The NDA: The Ins and Outs of the New Drug Application

One of the first steps in the process of becoming an approved drug is through the NDA, or New Drug Application. The application has been around in some form since 1938. The basic goal of the New Drug Application is to give the FDA valuable information that it needs to determine whether or not to approve the drug. The FDA must ensure that the drug is safe and of some usefulness. The FDA must also determine whether or not the side effects outweigh the benefits of the drug. Also considered is the literature that accompanies the drug, as well as whether or not the drug is produced in a way that maintains “identity, quality and purity.”

How Over-the-Counter Drugs are Approved

Over-the-counter drugs, known often as OTCs, have a special process that they must undergo before being approved by the FDA. According to the FDA itself, the organization applies the same standards to OTC drugs as it does to prescription drugs. OTC drugs must undergo what is known as a monograph, which, according to the FDA “represent(s) regulatory standards for the marketing of non-prescription drug products not covered by new drug applications.”

OTC drugs can also be produced by the switching of a prescription drug to one that is an over-the-counter drug. Often, this occurs when the drug is considered safe for use on a regular basis and has doses that are easy to understand and easy to administer. OTCs are categorized into three main categories: the product is safe, useful and correctly branded; the product is not considered safe, is not useful or may be misbranded; and there is not enough data for classification to occur.

Whether the product is OTC or prescription only, regulations still apply and the FDA works hard to approve safe medicines for the public.

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