Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article about a proposed rule by the Food and Drug Administration on postmarket safety reporting requirements for combination products.
In the article, “FDA Proposes Rule on Postmarket Safety Reporting for Combination Products,” Thompson said that the rule “clarifies what has been obscure to date.”
Thompson, who is general counsel of the Combination Products Coalition (CPC), said the CPC is “delighted the proposed rule is out.”
Some places in the proposed rule “are a little bit ambiguous and we’ll comment on it,” Thompson said. However, the proposed rule is a “useful starting point.”