FDA changing notices on drug decisions

U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said on Wednesday.

Companies have been receiving “approvable letters” indicating a drug could win approval later if certain steps were taken. Another option has been a “not approvable letter,” which typically meant the FDA wanted a substantial amount of additional data before considering approval.

Starting August 11, the FDA will end those types of letters and instead issue a “complete response” letter for drugs not ready for approval, with a description of deficiencies and recommended actions. The FDA has issued complete response letters for some products in the past.

“These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.