James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “The Hazy Future of the VALID Act,” by Maya Goldman. (Read the full version – subscription required.)
Following is an excerpt:
- As it waits for Congress to take action, the agency is moving forward with rulemaking on diagnostic testing regulation, an FDA official said this month.
- But using the rulemaking process for this issue would open the FDA up to lawsuits, which could delay things and “cause a lot of havoc,” said James Boiani, a lawyer at Epstein Becker Green who specializes in FDA and clinical lab regulations.