CDER Small Business Chronicles – Safety Labeling Changes for Prescription Drugs

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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FDA/CDER Small Business Chronicles – Safety Labeling Changes for Prescription Drugs

The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Safety Labeling Changes for Prescription Drugs. Section 505(o)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act authorized FDA to require and, if necessary, order labeling changes if FDA becomes aware of new safety information that FDA believes should be included in the labeling of the drug. It also imposed time frames for application holders to submit and for FDA staff to review such changes, and gives FDA new enforcement tools to bring about timely and appropriate safety labeling changes. 

The purpose of the newsletter, the FDA/CDER Small Business 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 at CDERSmallBusiness@fda.hhs.gov. 

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

  

Enjoy!

The CDER Small Business Assistance Team