Office of Generic Drugs

W. P. Adams and G. J. P. Singh. Guidance Topical dermatology corticosteroids In vivo bioequivalents, Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, 1995. 

Source (1) Parise C. Office of Generic Drugs, FDA, Framework for the Submis-... 

Policy and Procedure Guide 22-90 Interim Policy on Exceptions to the Batch-Size and Production Condition Requirements for Non-Antibiotic, Solid, Oral-Dosage Form Drug Products Supporting Proposed ANDA s , U.S. Department of Health and Human Services, Center for Drug Evaluation and Research, Office of Generic Drugs, September 13, 1990. 

Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs... 

For an ANDA, conducting an in vivo study on a strength that is not the highest may be appropriate for reasons of safety, subject to approval by the Division of Bioequivalence, Office of Generic Drugs, and provided that the following conditions are met. 

An ANDA contains data that, when submitted to the FDA s CDER, Office of Generic Drugs, provide 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. 

An applicant may submit all or portions of the archival copy of the application in any form that the applicant and the FDA agree is acceptable. Submission of electronic versions of the application are welcome but should be discussed with the Office of Generic Drugs prior to actual submission. 

Field Copy—Additional Guidance. In addition to the archival copy, domestic applicants must submit a certihcation (21CFR 314.94) that a true third/ field copy of the technical sections (CMC) of the application has been submitted to the appropriate FDA District Office. Foreign applicants should submit the field copy to the Office of Generic Drugs (see Appendix A for mailing address and specifications). 

Office of Generic Drugs CDER, FDA Metro Park North II 7500 Standish Place, Room 150 Rockville, MD 20855... 

Office of External Affairs Office of Epidemiology and Biostatistics (CDER) Organization for Economic Cooperation and Development Office of the General Counsel Office of Generic Drugs (CDER, formerly DGB)... 

Recommended designs for skin irritation and skin sensitization studies for the comparative evaluation of transdermal drug products for an abbreviated new drug application are delineated below. Other proposals for studies may be suggested, but potential applicants are advised to consult the Office of Generic Drugs about alternative study designs before the initiation of such a study. 

FDA/Center for Drug Evaluation and Research Office of Generic Drugs Division of Labeling and Program Support Update frequency ... 

In an article by Nerukar et al. [18] of the U.S. Office of Generic Drugs, published in 1992, it was mentioned that current FDA policy does not require the measurement of individual enantiomers to demonstrate bioequivalence. They indicated that they agreed in principle that because the pharmacodynamics of the enantiomers of a racemic drug may differ, generic applicants should measure each enantiomer to satisfy the bioequivalence requirements. They also stated, the office does not wish to impose a requirement for enantiospecific assays in the absence of compelling reasons to do so. Criteria for the compelling reasons were not specified in detail. 

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