505 New Drug Applications

The dossier is filed during phase III trials. Phase III trials that are included in the dossier are called phase Ilia trials. Phase Ilia trials test for items that are vital for FDA approval. The phase Illb trials are conducted after NDA filing and cover topics such as cost effectiveness and efficacy in comparison to existing therapies. 

In analyzing the full dossier, the FDA may request site visits at the pharmaceutical company and form special review committees to gain additional expertise. If additional information is needed, the sponsor must provide it, possibly requiring design of another phase III protocol or other test. A smooth NDA may be completed within 12 months. Once all FDA requests have been satisfied, the NDA is approved. The sponsoring pharmaceutical company may then market the drug. 

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New blue Newbuck Newcastle virus Newcomen s engine New Drug Application... 

New drug application (NDA), 165 New 1UPAC naming system, 177 New molecular entity (NME), number of, 164... 

A New Drug Application (NDA) is submitted after tiie investigation of the drug in Phases I, II, and III is... 

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

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. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

The file may be queried In response to questions from clinical staff at the National Institutes of Health and physlr-clans and laboratory scientists throughout the country who submit their problems by letter or telephone The file has been used to provide Information for a pharmaceutical manufacturing company preparing a new drug application to the Food and Drug Administration For the latter organlzatloi the file has been... 

Quantitative data indicate a general increase in the number of clinical trial applications in Australia, Cuba, Estonia, Malaysia and Venezuela for the period 1994-97. Figure 8.11 shows the four-year average number of clinical trial applications received by the relevant authorities in these countries. During this period, the number of clinical trial applications in Australia far exceeded those received in all the other countries combined. The same is also true when the number of applications is computed against the number of new drug applications (Figure 8.12). 

Figure 8.12 Number of clinical trials requested per new drug application ...

A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use. 

Salmeterol is also available in a fixed ratio combination product containing fluticasone, and a new drug application has been filed for a fixed combination product containing budesonide and formoterol. Combination products have the potential advantage of increasing patient adherence due to the decreased number of inhalers and inhalations however, these products offer less flexibility with respect to dosage adjustments when necessary. 

Abbreviated New Drug Application antithyroglobulin antibody antithyroid peroxidase antibody area under the (time-concentration) curve beta-human chorionic gonadotropin central nervous system... 

Phase 3 trials are large-scale clinical trials on populations numbering in the hundreds to thousands of patients. These are the critical trials that the drug maker runs to show that its new drug is both safe and efficacious in the target study population. If the phase 3 trials are successful, they will form the keystone elements of a New Drug Application... 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

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