Regulatory submissions electronic

Providing Regulatory Submissions in Electronic Format - General Considerations ... 

Food and Drug Administration. Guidance for Industry, Providing Regulatory Submissions In Electronic Format—General, FDA, Rockville, MD, 1999. 

More rigorous demands for the format of regulatory submissions. The FDA initiatives to eliminate unnecessary paperwork through electronic... 

U.S. Department of Health and Human Services (2006), Guidance for industry Providing regulatory submissions in electronic format—Human pharmaceutical product applications and related submissions using the eCTD specifications, Food and Drug Administration, Rockville, MD. 

Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER). Guidance for Industry. Regulatory Submissions in Electronic Format General Considerations, Jan. 28,1999. 

Regulatory Submissions in Electronic Format New Drug Applications, Jan. 28,1999. 

Electronic Regulatory Submissions and Review (CDER) This document (from http //www.fda.gov/cder/regulatory/ersr/default.htm) provides specific ESG guidance for CDER submissions, including NDAs, INDs, and DMFs. 

Drug Master File (DMF). Refer to the Guidance for Industry Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications for information on the submission of electronic DMFs. 

Draft Guidance Providing Regulatory Submissions in Electronic Format-Prescription Drug Advertising and Promotional Labeling. Optional format PDF. (Issued January 2001, Posted January 30,2001)... 

DFS is being developed incrementally. The first phase focuses on building an electronic repository for final review documents and for capturing signature information. The review documents tracked and saved by DFS are associated with regulatory submissions in the Centerwide Oracle Management Information System (COMIS). Future phases of DFS will include an update of COMIS... 

Format and tables conform to Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs)... 

GUIDANCE FOR INDUSTRY PROVIDING REGULATORY SUBMISSIONS TO CBER IN ELECTRONIC FORMAT—INDS... 

In this guidance, we discuss specific issues unique to the electronic submission of INDs and their amendments. We have described general issues such as acceptable file formats, media, and submission procedures that are common to all submissions in the companion guidance, Providing Regulatory Submissions in Electronic Format—General Considerations, dated January 1999 (January 28,1999,64 FR 4433). 

For more details concerning electronic submissions, see Electronic Regulatory Submission and Review (ERSR) guidelines.]... 

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