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 Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Combo Product Sponsors Convince US FDA to Change Postmarket Reporting Rule,” by Michael Cipriano. (Read the full version – subscription required.)
Following is an excerpt:
Thompson in particular praised the rule’s clarification of the different requirements that are applicable to the combination product applicant those that are applicable to constituent product applicants. For example, the final rule makes clear that the requirement to share information that involves a death or serious injury with other constituent part applicants within five calendar days only applies to constituent part applicants. It also clarifies that additional reporting requirements under Section 4.102(c) to address specific safety concerns related to medical devices and biological products – that are not in the proposed rule – only apply to combination product applicants.
“This was a particularly gray area, and the changes the agency made are very helpful. In the original proposed rule, there were some ambiguities that might be interpreted as actually expanding the PMSR requirements for constituent product manufacturers and even component suppliers,” Thompson said. “The final rule puts those issues to rest.”