Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Combination Product Reporting Rule Set for 2020 Enforcement,” by Elizabeth Orr. (Read the full version – subscription required.)
Following is an excerpt:
Long-delayed changes to the US Food and Drug Administration’s approach to postmarket safety reporting for combination products are set to start coming into effect in 2020, following the agency’s recent release of a final guidance document on the issue. …
Industry Praises the Move
Early industry reaction to the guidance document was generally positive. …
And the final document seems to be written with an eye to industry concerns, said Combination Products Coalition general counsel Bradley Merrill Thompson.
“At least based on a quick review, it appears that the FDA has addressed comments provided by industry on topics like follow-up reports, details to be included in the periodic safety reports, foreign events, same or similar devices and information-sharing responsibilities,” he said.
He also praised the document’s clarity and organization, but said its approach to a few topics was “not necessarily the least burdensome.”
For example, he said the process laid out in the document for submitting reports marketed only outside the US wouldn’t work for if the product had no close US equivalent.
“We’re going to need to spend more time with the document to understand what the FDA is truly saying,” he said.