FDA WITHDRAWS GUIDANCE DUE TO FORMAT CHANGES

The FDA is withdrawing three electronic new drug application (NDA) and abbreviated new drug application (ANDA) guidances because the agency wants companies to adhere to a single format for submissions.

In a notice published in the Sept. 29 Federal Register, the FDA announced it is withdrawing the following guidances: "Providing Submissions in Electronic Format -- NDAs;" "Providing Regulatory Submissions in Electronic Format -- ANDAs;" and "Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs."

The agency is withdrawing these guidances because it is changing the format it requires for these documents from portable document files (PDF) to extensible markup language (XML). Previously, submissions could be in either format, which presented problems for both industry and the agency, the agency said.

"A result of having this variety of choices is confusion and frustration for industry, who are not receiving consistent recommendations about how to submit marketing applications," the agency said. "It is also confusing and frustrating for our review staff. In addition, our willingness to receive applications in a variety of different forms has forced the agency to maintain expensive and duplicative processes and systems for receiving and archiving these various application types."

The notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/99d-0054-nwl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/99d-0054-nwl0001.pdf).