Regulatory Focus™ > News Articles > FDA Releases New Safety Communication Strategy

FDA Releases New Safety Communication Strategy

Posted 08 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released draft guidance on 8 March on how it intends to communicate with the public about drug safety issues, including important topics and emerging information.

"The revised guidance describes the Center for Drug Evaluation and Research's (CDER's) single, standardized format for electronic drug safety communications about marketed drugs and provides information about the Center for Biologics Evaluation and Research's (CBER's) safety communication activities, writes FDA. "In addition, the revised guidance describes FDA's posting of other safety assessments on its Web site in accordance with the requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and to further our transparency objectives."

When completed, the communication guidance will replace an earlier strategy formulated in 2007.

The guidance includes information about how FDA evaluates drug safety information, when it communicates information to the public, how it communicates information to the public, how it revises product labeling in response to new information, differences between CDER and CBER drug communications, how information is handled and updated, and other miscellaneous information.

Comments on the document are due 60 days after publication in the Federal Register.

Read more:

Guidance - Drug Safety Information - FDA's Communication to the Public

Federal Register - Draft Guidance on Drug Safety Information; Availability: FDA's Communication to the Public

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