New drug applications content

Guarino RA. The new drug application, content and format. In New Drug Approval Process. 4th edition. Accelerating Global Registrations. Guarino RA, ed. 2004. Marcel Dekker, Inc., New York. pp. 113-172. 

Lumpkin, M. (1996). Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including well-characterized, therapeutic, and biotechnology-derived products, http //www.fda.gov/cder/guidance/phasel.pdf... 

Content and format of an abbreviated application Refusal to approve an abbreviated new drug application... 

Agenda for the Electronic Investigational New Drug Application Cumulative Table of Contents (CTOC) Public Meeting. (Posted January 22, 2001)... 

Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (draft guidance) (November 2004) Current Good Tissue Practices for Human Cell, Tissue, and Cellular Tissue-Based Product Establishments Inspection and Enforcement (November 2004)... 

An applicant may provide an overall summary of data from controlled studies. This section is optional and many firms do not include it because the results of the studies are presented in the integrated summaries of efficacy and safety, which will be discussed later in this chapter. The Guidelines for the Clinical and Statistical Sections of a New Drug Application also address the format and content of an integrated clinical/statistical report for a clinical study this too will be discussed later. 

The FDA generated a guidance document regarding the content and format of an ANDA entitled Guidance for Industry Organization of an Abbreviated New Drug Application and an Abbreviated Antibiotic Application (February, 1999). ... 

C Kumkumian. New Drug Application Chemistry Review. Format and Content Guide. June, 1992. 

The following synopsis of the FDA s expectations is based heavily on the Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. The report will include at least the following ... 

The current global initiative to harmonize electronic submission format and content requirements effectively creates one standard data package for drugs or biologies. Thus, the eNDA (electronic new drug application) or eBLA (electronic biologies license application) will eventually be replaced by the eCTD (electronic common technical document). 

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