The FDA has chosen a new director for its Office of Drug Safety and widened the office's responsibilities. Gerald J. Dal Pan, M.D., will now lead the agency's office in charge of post-marketing drug safety. The office operates inside the Center for Drug Evaluation and Research. A staff reorganization will be laid out in coming weeks to better position CDER with its goals on public safety.
The Office of Drug Safety had come under intense scrutiny after FDA insiders told Congress that the agency had abdicated its responsibilities to safeguard the public in favor of easing regulations for drug developers. Since then, the agency has been steadily ratcheting up its focus on pharmacovigilance plans to track potential safety problems after a drug is approved for widespread use.
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