CDER SBIA Chronicles: Drug Shortages – Make an Impact
The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Drug Shortages, and how industry can make an impact to help prevent and alleviate this problem.
FDA is concerned about the high incidences of drug shortages in the U.S., especially for drugs that are manufactured by a few firms and lack optimal therapeutic substitutes in adequate supply. Manufacturers can play a critical role in decreasing the impact of shortages by notifying FDA of incidents that may result in a drug shortage or potential disruption in supply. Preventing drug shortages has been, and continues to be, a top priority for FDA.
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 at CDERSBIA@fda.hhs.gov.
Our previous newsletters are also archived on our webpage at: http://www.fda.gov/
The CDER Small Business and Industry Assistance Team