Resources for Food and Drug Administration (FDA)

FDA Decisions On Drug Approval Could Start Slipping

blogs.wsj.com

Ever since the drug industry started funding the FDA’s review of drugs for approval, the agency’s been pretty diligent about responding to applicants on schedule. But there are signs the agency may soon start slipping, the In Vivo blog reports this morning.

The head of the FDA’s Office of New Drugs, John Jenkins, has given unofficial permission for the office to miss deadlines on approval decisions, which could lead to the agency missing more than 10% of its approval deadlines this year, according to a BioCentury story cited by In Vivo.

New scrutiny over everything from overseas inspections to postmarketing surveillance has given the agency “more work on our plate than we can possibly accomplish,” Jenkins reportedly told BioCentury. “We are having to prioritize. We are having to set aside some things, hopefully on a temporary basis, until we can get adequately staffed.”

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