FDA ISSUES GUIDANCE ON MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR PET DRUGS

The FDA has released the final Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs.

This guidance is being issued consistent with FDA’s good guidance practices regulation. The guidance represents the Agency’s current thinking on media fills and process simulations for PET drugs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

To view the guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf

Advertisements
This entry was posted in PET Drugs. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s