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Posted 10 December 2014 | By Alexander Gaffney, RAC,
More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates.
Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative, have involved patients in more than a dozen meetings and solicited extensive feedback. Others, such as its medical device-focused Patient Preference Initiative (PPI) are still in the early stages of development.
Then, in November 2014, FDA issued an announcement in the Federal Register asking for feedback—and especially feedback from patient groups—about its patient-centric activities, as well as patients' views about the medical product development process.
For more on FDA's announcement, please see our story, "Is FDA Listening Enough to Patients? Agency Wants Feedback."
Now patients and patient advocacy groups alike are responding to FDA's solicitation, offering the agency advice.
Some selected advice follows:
All comments may be found here.
Tags: FDASIA, Patients, Patient Groups, Patient-Centered Drug Development, FDASIA Section 917, Recommendations for FDA
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