Drug Master File

It should be noted that all technical data submitted in support of marketing authorisations remain confidential between the applicant and the regulatory authorities. In situations where the manufacturer of a drug substance is a different commercial entity to the applicant seeking approval of a drug product incorporating 

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LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

Letters of authorization for reference to other applications or drug master files Waiver requests... 

Drug Master Files Investigational New Drug Application New Drug Application... 

Information on existing or new excipients can be described and provided to the FDA in an NDA directly. Alternatively, the manufacturers of excipients may prepare and submit type IV Drug Master Files (DMF) to support the use of an excipient in one or more NDAs. The DMFs are discussed in FDA s regulations under 21 CFR Section 314.420 and the FDA-issued Guidance for Drug Master Files (8). When authorized by the DMF submitter (i.e., the excipient manufacturer) and cross-referenced by an NDA submitter, the FDA reviews the DMF to make determinations on the safety, manufacture, and quality of the excipient use in the new drug that is the subject of the then pending NDA. The DMF becomes active when reviewed in conjunction with the review and approval of an NDA. 

The FDA Guideline for Drug Master Files (21 CFR Part 314.420) consists of the following sections ... 

Food and Drug Administration. Cover Form for the Technical Review of Drug Master Files, FDA, Rockville, MD, 1998. 

Drug Master File deoxyribonucleic acid design qualification effective dose... 

Packaging/labeling DMF (drug master file) Applicable law/arbitration... 

There are four basic sensations salty, bitter, sweet, and sour. A combination of efforts is required to mask these tastes. For example, menthol and chloroform act as desensitizing agents a large number of natural and artificial flavors and their combinations are available to mask the bitterness most often found in organic compounds. Most formulators refer the selection of compatible flavors to companies manufacturing these flavors, as they may allow use of their drug master file... 

FDA Guidance for Drug Master Files September 1, 1989. Guidance documents, published by the FDA, represent the agency s current thinking on a particular subject. They can be accessed at www.fda.gov/cder/guidance/index.htm. 

Table 3 indicates the preclinical safety studies for CAPTISOL (25) conducted as of 2005. The strategic safety plan for CAPTISOL was designed based on the guidelines discussed in the 1990s by the International Pharmaceutical Excipients Council which resulted in the May 2005 issuance of the FDA Guidance (26) Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. These studies and others in the CAPTISOL Drug Master File have delineated the safety of CAPTISOL (SBE7-P-CD) for parenteral, ophthalmic, oral, nasal, and inhalation administration. 

CyDex Inc., Drug Master File No. 14364, 10513 West 84th Terrace, Lenexa, Kansas 66214, U.S.A. 

Analytical reagents used in testing the excipients should be prepared and labeled following established procedures. Retest or expiration dates should be used, as appropriate, for analytical reagents, or standard solutions. Analytical methods should be validated unless the method employed is set forth in the current revision of the United States Pharmacopeia/National Formulary, Association of Official Analytical Chemists (AOAC), Book of Methods, or other recognized standard references, or detailed in the Drug Master File or approved New Drug Application and are used unmodified. 

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