Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled "PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide." FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand FDA's thinking on compliance with the positron emission tomography drugs (PET) CGMP regulations, including appropriate resources, procedures, and documentation for PET drug production facilities.