jueves, 1 de septiembre de 2016

Drug Safety Labeling Changes - data available in new, user-friendly format

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

The Drug Safety Labeling Changes Program has moved from the Office of the Commissioner’s MedWatch Program to CDER’s Office of Communications (OCOMM). With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technology vendors, and the public to view, search, and download.
Before today, the MedWatch program posted safety labeling changes on a monthly basis. Now, the SLCs will be housed in a CDER database and be published as close to the day of the labeling supplement approval as possible. Prompt access to these vitally important safety data will ultimately benefit patients as this information will be communicated to their health care providers in a much more timely manner. The new CDER database will include SLC data from January 2016 forward. Data prior to January will continue to be available on theMedWatch Web site.

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