New drug applications , FDA

Food and Drug Administration. Investigational New Drug Application, FDA, 21 CFR Part 312. 

Prescription Drug User Fee Act (1992) Reauthorized 1997 and 2002. Manufacturers pay user fees for certain new drug applications. FDA claims review time for new chemical entities dropped from 30 months in 1992 to 20 months in 1994. 

RCT randomized, controlled trial NDAs new drug applications FDA Food and Drug Administration FD C Act Food, Drug, and Cosmetic Act IND investigational new drug ADE adverse drug event... 

NDA New Drug Application FDA approval to market a new drug for ordinary medical clinical use... 

CFR Title 21, Part 312—Investigational new drug application (FDA, 2003a)... 

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. 

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. 

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. 

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

On completion of phase III trials, the data will be checked to see that it fulfils all the criteria required to generate a viable, marketable drag. The company will then file a New Drug Application (NDA), with the intention of proving the efficacy and safety of the drug in this therapeutic application. The NDA will contain all the clinical data and all relevant preclinical data for review by the FDA. Application reviews were 16.2 months on average in 1997 [75]. 

Intellectual Property In general, the investigator retains ownership and development rights to their invention, consistent with Bayh-Dole provisions [4]. The investigator is expected to submit an Investigational New Drug Application (INDA) with the FDA under their own sponsorship. Specific information can be found at the NIH-RAID website. 

Scott, R., "FDA Requires New Drug Applications Present Effectiveness and Safety Data for Gender, Racial and Age Sub-Groups" (2001),... 

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