US FDA Touts Benefits From Remote Assessments, Manufacturers Feel Burden – Trade Groups
CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”
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Gathering GMP information can be as problematic for agency as keeping tabs on all supplements available to US consumers. “Just to be clear, FDA believes we have a data gap in understanding the extent of the dietary supplements in the marketplace,” says ODSP Director Cara Welch.
“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.
Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.