Other NDAs

Stability protocols for new combination products or new formulations (which require clinical data for approval) should follow the guidance in the ICH Q1A in principle. 

However, a reduced stability database at submission time (e.g., 6 months accelerated and 6 months data from ongoing studies at the long-term condition) may be acceptable in certain justified cases, such as when there is a significant body of information on the stability of the drug product and the dosage form. 

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This section should contain a complete alphabetical list of all the names and addresses of all known investigators that the applicant supplied with the drug substance or product. In addition, all dosage forms used by these investigators should be stated. This list should also include the kinds of studies carried out, study identifier, location of each report, case report tabulations, and case report forms. In addition, a list of all known INDs under which the drug was studied and any other NDAs submitted for the same drug substance should be included. 

The commercial viability of a CD formulation has been established with the marketing of 20 products (Table 1). Two of these products are currently on the market in the United States one product (oral and parenteral formulations) containing a derivatized CD and the other containing a-CD. Numerous clinical trials using CD formulations have, however, been conducted or are in progress in the United States, with at least one other NDA under review. 

NOTE Breakdown of NMEs versus other NDAs not available prior to 1980. 

Another distinct class of dmgs are those requiring a prescription or a written order from a physician or health professional. Congress authorized PDA to determine whether a dmg should be a prescription dmg. Typically prescription dmgs are those that (/) have habit-forming characteristics (2) requke a physician s supervision, because of toxic or other harmful effects, methods of use, or coUateral measures necessary for use or (J) are limited to prescription use under an NDA. 

Cla.ss II Performance Sta.nda.rds. This category regulates devices for which General Controls are not sufficient to ensure safety and effectiveness. Class 11 controls iaclude all the controls ia Class 1. In addition, manufacturers of sutures ia Class 11 must give the EDA 90-days notice of their iatent to market the suture, by way of a 510(k) filing providing data to show that the suture is "substantially equivalent" to an already-approved device. Most sutures were reclassified iato Class 11 ia 1989. Other than USP standards, performance standards for sutures have not actually been promulgated, but the EDA has taken the stand that sufficient information exists ia the pubHshed Hterature to ensure the safety and effectiveness of sutures ia this class. 

Analysis of the study reports shows that the MEB in the Netherlands and the dmg regulatory authorities of Uganda and Zimbabwe are organized in a board format. The MEB, which is the main DRA in the Netherlands, is organized as a board whose members are appointed directly by the Crown. This appointment procedure makes it relatively free from the influence of other Government bodies. The MCAZ and the Ugandan NDA are also established as statutory authorities, with executive committees plus some specialized advisory committees. Although board members are appointed by the Minister of Health, their independence is established by statute. 

Upon completion of clinical trials, the sponsor will collate all the preclinical, clinical and other pertinent data (Table 4.10) and submit this to FDA in support of an application to allow the new drug to be placed upon the market. For CDER-related drugs, this submission document is termed an NDA. 

Phase Ilia. Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase Ilia clinical trials generate additional data... 

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