The FDA has announced a public meeting to discuss the proposed Generic Drug User Fee Act.

The Food and Drug Administration (FDA) has announced it will hold a public meeting to discuss the proposed recommendations for the Generic Drug User Fee Act (GDUFA), which will authorize FDA to collect fees and use them for the process for the review of human generic drug applications and associated Type II Active Pharmaceutical ingredient Drug Master Files (DMFs) and for conducting associated inspections for fiscal years 2013-2117.

The meeting will be held at the FDA’s White Oak Campus, Silver Spring, MD, on Monday, December 19th from 8:00am to 5:00pm ET. Registration is required to attend and must be received by December 12, 2011. The meeting will also be webcast.

For more information, please view the Federal Register announcement: http://www.gpo.gov/fdsys/pkg/FR-2011-12-08/html/2011-31630.htm

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 )

Connecting to %s