Because federal law states that only marketed drugs are permitted to be transported across states lines, the IND provides a legal framework that allows Sponsors to transport their investigational products to clinical investigators in different states.
INDs may be categorized as either commercial or research. Commercial INDs allow for the development of a drug or biologic with the goal of ultimately submitting a marketing application. Research INDs involve therapies that are not intended for commercialization but are being investigated strictly for research purposes e. In addition to these two primary designations, emergency INDs a type of expanded access IND application may be submitted by physicians to allow treatment of immediately life-threatening conditions when no standard acceptable treatment is available and insufficient time exists to receive Investigational Review Board IRB approval.
Regardless of the type of IND, all IND applications must include information about the quality and nonclinical safety of the investigational product as well as the proposed clinical protocol and investigator. The goals of the NDA are to provide enough evidence to support the safety and effectiveness of the drug and to show that the benefits of its use outweigh the risks.
In addition, the FDA will review the proposed labeling for the drug i. However, the NDA is much more comprehensive than the IND and is expected to provide very detailed information about the drug. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product.
A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product.
If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Important Addresses for Regulatory Submissions. The pages in this section give detailed information about the following types of applications: Investigational New Drug IND Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical animal and clinical human data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is performs in the same manner as the innovator drug. One way applicants demonstrate that a generic product performs in the same way as the innovator drug is to measure the time it takes the generic drug to reach the bloodstream in healthy volunteers.
To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. The " Drug Price Competition and Patent Term Restoration Act of ," also known as the Hatch-Waxman Amendments, established bioequivalence as the basis for approving generic copies of drug products.
These Amendments permit FDA to approve applications to market generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish safety and efficacy. Under the Hatch-Waxman Amendments, brand-name companies gained patent term extension to account for the time the patented product is under review by FDA and also gained certain periods of marketing exclusivity.
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