FDA Environmental Assessment Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity

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Environmental Assessment Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity[附网盘链接]是于当前发布的FDA标准，适用于美国。

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Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to supplement FDA’s guidance for industry on Environmental 2

Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in the environment. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EAs) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. BACKGROUND 3

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses. To comply with NEPA, the Food and Drug Administration (FDA) considers the environmental impacts of its actions as an integral part of its regulatory process. FDA regulations at 21 CFR part 25 specify that EAs must be submitted as part of certain NDAs, abbreviated new drug applications (ANDAs), biologic license applications (BLAs), supplements to such applications, and investigational new drug applications (INDs), as 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 3

See http://www.nepa.gov.

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