Abbreviated New Drug Application
Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. 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. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). 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 bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. 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. Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. For more information on generic drug bioequivalency requirements, please see the chapter entitled "FDA Ensures Equivalence of Generic Drugs" in "From Test Tube to Patient: Improving Health Through Human Drugs." The Office of Generic Drugs home page provides additional information to generic drug developers, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
Generics Generics (Draft - Distributed for comment purposes only). Procedural Draft: Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999). This provision permits FDA to rely, for approval of an NDA, on data not developed by the applicant. Biopharmaceutics. o Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. (Issued 10/2000, Posted 10/27/2000). This guidance should be useful for applicants planning to conduct
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bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs. Drug Master Files. A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders Guidance for Industry: Changes to an Approved NDA or ANDA Refusal to Receive. (Issued 7/12/1993, Posted 11/26/99) Clarifies CDER's decisions to refuse to receive an incomplete application. Inactive Ingredient Database. This database contains all inactive ingredients present in approved drug products or conditionally approved drug products currently marketed for human use.
21CFR Part 314 Applications for FDA Approval to Market a New Drug or and Antibiotic Drug 21CFR Part 320 Bioavailability and Bioequivalence Requirements. For more information on retention samples, please see Bioequivalence Study Retention Samples. o Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule. (PDF - 66KB) 21CFR Part 310 New Drugs
MaPPs
CDER's Manual of Policies and Procedures (MaPPs) provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external. MaPPs define external activities as well. All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures. MaPP documents to help prepare ANDAs are listed together on CDER's Manual of Policies and Procedures webpage.
Related Topics
Investigational New Drug Application (IND). Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects. New Drug Application (NDA). Provides resources to assist drug sponsors with submitting applications for approval to market a new drug. Drug Application Regulatory Compliance The approval process for new drug applications includes a review of the manufacturer's compliance with Current Good Manufacturing Practice. This web page provides resources to help meet compliance. Information for Clinical Investigators . Provides regulations and guidelines to scientists who design and run experiments (clinical trials) to test the safety and effectiveness of new drugs on human subjects. Small Business Assistance Program. Electronic Regulatory Submission and Review (ERSR). Provides information on electronic drug applications, application reviews, Electronic Document Room, and other ERSR projects. Post Drug-Approval Activities. The goal of CDER's post drug-approval activities is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Appro valApplications/AbbreviatedNewDrugApplicationANDAGenerics/