Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability

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概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information." This guidance provides recommendations to industry on formal meetings between sponsors of investigational new drug applications (INDs) and the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) on chemistry, manufacturing, and controls (CMC) information.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability

Office of Management and Budget (OMB) に提出された情報収集活動; Food and Drug Administration (FDA) の提出書類の提出; Customer/Partner Customer Service Satisfaction Surveys に関するコメントの要求

Agency Information Collection Activities: Proposed Collection; Comment Request

Office of the National Coordinator for Health Information Technology; Health Information Technology Advisory Committee; エンタイントにそすにしたプログルにしたプログにプログを定义にしたプログに。