CDER SBIA Chronicles: Registration and Drug Listing

CDER SBIA Chronicles: Registration and Drug Listing 

The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Who, What, When, and How of Registration and Drug Listing.

Registration and drug listing allows FDA to develop and maintain a catalog of all drug products marketed in the U.S. Registration information provides the locations and contact information for drug establishments and determines sites for inspection. Drug product listing information provides an inventory of all drug products in circulation as well as manufacturing information, including inactive ingredients incorporated into marketed drug products. The FDA relies on registration and listing information for administering many key programs, including post-marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.  

The purpose of this newsletter, the FDA/CDER SBIA Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation. As always, we would appreciate your input regarding topics that you would like us to write about. If you have topics of interest, please email us atCDERSBIA@fda.hhs.gov. 

Our previous newsletters are also archived on our webpage at: http://www.fda.gov/cdersmallbusinesschronicles.

  

Enjoy!

The CDER Small Business and Industry Assistance Team 

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation