Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Industry Praises Combo Product Rule But Still Seeks New Postmarket System,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
Thompson emphasized Monday the need for specific case studies to be included in the upcoming guidances.
“On several occasions, FDA notes the need to publish a guidance interpreting this now final rule. We have been urging FDA to move forward with that guidance because we anticipated that there would be ambiguities that need the kind of clarity that can only come with guidance. In particular, it will be very important for FDA to go through some case studies to illustrate exactly how these requirements apply,” Thompson wrote….
Thompson, who had called for a revised implementation timeline in comments on the proposed rule, praised the extension.
“While much of the final rule simply reinforces the existing rules imposed on drugs, devices and biological products, there are sections such as 4.103 which create new obligations. The agency has quite sensibly given industry now 18 months to put these new required procedures in place,” Thompson wrote.