FDA defines drugs as
- a substance recognized by an official pharmacopoeia or formulary.
- a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- a substance (other than food) intended to affect the structure or any function of the body.
- a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
FDA’s Center for Drug Evaluation and Research (CDER) regulates
■ Over-the-counter and prescription drugs including biological therapeutics and generic drugs
■ Fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, hand sanitizers that are considered “drugs”
■ Prescription Drugs: medicines or any drug product that requires a doctor’s authorization for purchase.
■ Generic Drugs: drug products equivalent to brand name products in terms of quality and performance. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
■ Over-the-Counter (OTC) Drugs: drug products are available to consumers without a doctor’s prescription.
All Drug Establishments must renew their registration between October 1 and December 31, 2022.
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
■ Drug Establishment Registration
■ Drug Product Listing
■ Investigational New Drug (IND) Application
■ New Drug Application (NDA)
■ Abbreviated New Drug Application (ANDA): Generics
■ U.S. Agent Service
■ Label Review
■ Label Design
Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA. There are exemptions.
- Company registration
- Product listing
- U.S. Agent Service for foreign companies
- Available at extra cost: Label Review or Update, U.S. Toll Free Number with international call forwarding, Certificate of FDA Registration
These fees apply to the period from October 1, 2021, through September 30, 2022, and are paid to the U.S. Treasury. An account is required.
|User Fee Type||2021|
|Application Fee – Clinical Data Required||$2,875,842|
|Application Fee – No Clinical Data Required||$1,437,921|
|User Fee Type||2022|
|Application Fee – Clinical Data Required||$3,117,218|
|Application Fee – No Clinical Data Required||$1,558,609|
The United States Food and Drug Administration may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including there are no adequate, approved, and available alternatives.
FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen.
In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regiment.
FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.