By Michael McCaughan
Everyone seems to agree that risk management programs are a big part of the answer to resolving concerns about the...
The Risk of Risk Management
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Risk management plans are an increasingly common feature of new drug approvals, and Congress seems set on making them a standard part of the FDA review process. Industry seems willing to go along, accepting some more restricitions on new products in exchange for restoring confidence in drug safety. There is only one problem: FDA is not so sure this is a great idea.
Learn what's happening at the US FDA. On the go.
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