A submission must be made to the FDA before a drug can be sold to the public.
The Food and Drug Administration (FDA) requires that anyone wishing to market a new drug, medical device, food, cosmetic or tobacco product must submit an application before and during the product testing process. Submissions to the FDA are reviewed thoroughly to ensure that the general public will not be at risk when consuming or using a new product. The type of submission required will depend on the current phase of the clinical trial and the type of product being tested.
Investigational New Drug (IND)
An IND submission is more like an exemption from the current drug shipping regulations as opposed to an approval of a product. Transporting of drugs requires an approved marketing application, but since drugs for clinical trials are not approved yet, an IND must be initiated to ship drugs for the purpose of a clinical trial.
New Drug Application (NDA)
A NDA submission is required when enough data has been collected on a new product and the manufacturer wishes to market the product. The FDA will be looking for proof of product safety and efficacy when considering a NDA.
Abbreviated New Drug Application for Generics (ANDA)
An ANDA submission is used when attempting to obtain approval for generic drugs. Less data is required with this submission than for a NDA, but applicants must prove the generic version is as effective as the original.
Biologic License Application (BLA)
Biological products require a license to be sold and the submission must contain information on how the product is made as well as its pharmacology, chemistry and medical effects.
Over the Counter Drugs (OTC)
OTC drugs do not require a prescription; however, the FDA still requires a submission for these drugs to ensure that they are properly labeled and will not harm the public.
Tags: clinical trial, Drug Application, ensure that, submission must, submission required
