이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 2013. 5. 2.1 분 읽기
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →