 |
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On Thursday April 24, 2014, at 1 pm EDT, CDER Small Business and Industry Assistance (CDER SBIA) will present a webinar entitled Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities.
The purpose of this webinar is to announce the recently-published human drug compounding fee draft guidance for industry and, in particular, to draw attention to the current open period for small businesses to request a reduction in the required establishment fee. Qualified small businesses pay a fee that is one-third the amount of non-small businesses. The draft guidance covers fee requirements for human drug compounding outsourcing facilities that have elected to register with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B requires outsourcing facilities to pay certain fees.
For more information, please visit: CDER SBIA Webinar
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
