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The FDA’s CDER reorganization plans are not an effort to address lawmakers’ concerns about a lack of independence — but rather an attempt to further the agency’s Critical Path initiative and improve its drug safety efforts, an FDA official says.
The FDA’s Center for Drug Evaluation and Research (CDER) has issued a new manual of policies and procedures (MAPP) that its employees must follow when submitting human subject research for the agency’s review.
The FDA is considering using academic research into the way people process information to redesign the agency's website and improve its delivery of drug safety information to consumers, according to FDA officials.
The FDA’s recently announced restructuring of the Center for Drug Evaluation and Research (CDER) should help address concerns that the FDA’s message promoting drug safety was inconsistent with the attention the issue was receiving, according to a top agency official.
The FDA’s recently announced restructuring of the Center for Drug Evaluation and Research (CDER) should help address concerns that the FDA’s message promoting drug safety was inconsistent with the attention the issue was receiving, according to a top agency official.
The FDA's proposed realignment of the Center for Drug Evaluation and Research (CDER) calls for the creation of a new office dedicated to the agency's Critical Path Initiative, as well as a major restructuring of the center's drug safety activities.
The FDA's proposed realignment of the Center for Drug Evaluation and Research (CDER) calls for the creation of a new office dedicated to the agency's Critical Path Initiative, as well as a major restructuring of the center's drug safety activities.
Following a "broad" four-month nationwide search, the FDA has selected an internal candidate to fill the long-vacated director position in its Office of Drug Safety (ODS), the agency announced Oct. 19.
Public interest groups are concerned that an FDA initiative to use risk-based reviews to speed drug approvals could cause more problems than it solves.