FDA Largely Rejects Prometheus Petition On Drug Risks

Law360, New York (October 21, 2013, 4:37 PM EDT) -- The U.S. Food and Drug Administration has told Prometheus Laboratories Inc. that it won't quickly develop regulations clarifying how rival drugmakers should craft required risk-reduction measures and downplayed concerns that unanswered questions may trigger antitrust cases, according to a letter released Monday.

In the response to a citizen petition that Prometheus lodged in May, regulators said that while they are considering initiating rulemaking or issuing guidance on so-called single, shared risk evaluation and mitigation strategies, there will be no immediate action.

However, FDA in its Oct....
To view the full article, register now.