Drugs

More Changes Urged in RRA Revised Guidance Comments

AdvaMed says it appreciates that FDA issued a revised draft guidance on questions and answers about conducting remote regulatory assessments (RRA) and continues to support the concept of RRAs. In its comment letter, AdvaMed says it is “important that RRAs be implemented in a manner that both serves FDA’s objectives and facilitates an efficient collection of information.”

While appreciating that the agency incorporated some of its comments from its response to an earlier version of the draft, AdvaMed says that many of its comments that were not addressed are still important to resolve. It particularly asks that FDA clarify that only RRAs covering document requests are mandatory for medical devices. It also reiterates its position that FDA should issue a formal report after all device RRAs and the final report should not be optional. The letter includes the association’s detailed line-by-line comments.

In its response, Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports FDA’s use of alternative tools for oversight of regulated products and appreciates the changes made in the revised draft. “We agree with FDA that RRAs can help enhance FDA’s oversight of regulated products,” it says.

The letter contains recommendations to modify the draft to enhance clarity and help further facilitate the agency’s use of the tools.

The Association of Contract Research Organizations (ARCO) says some site establishments have not fully converted from pen-and-paper approaches to using digital electronic records. Because it would be difficult for sites that still use a pen-and-paper approach to comply with the electronic nature of mandatory RRAs, it says, FDA should use the final guidance as an opportunity to strongly encourage all research sites to fully convert to the use of electronic records. ARCO also submits several line-by-line recommendations.

Finally, the Biotechnology Innovation Organization references its previous comments, with an emphasis on those that were not addressed in the revised draft, including the applicability of RRAs during pre-approval/pre-licensure and routine surveillance inspection scenarios. It also provides a table of specific line-by-line comments.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome