New FDA cGMP Guidance for Small Businesses Available

August 5, 2011

New FDA cGMP Guidance for Small Businesses Available

The Food and Drug Administration (FDA) has announced the availability of a guidance for small business entities entitled ‘‘PET Drugs— Current Good Manufacturing Practice(CGMP); Small Entity Compliance Guide.’’ The guideline 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.