Modern Healthcare (02/12/12) Lee, Jaimy
The FDA recently issued a draft guidance for safety data that companies who develop drug and biological products ought to collect in the late-stage, pre-market and post-market clinical trials. The guidance calls for more selectivity in data collection in order to improve the safety database, which would help lower costs, and ease the burden on participating patients and clinical investigators. The FDA feels that, for those clinical trials which have already established the drug safety profile, comprehensive data should not be required. In the draft guidance, the FDA has also noted that any data collection considered to be 'excessive' or not useful may be seen as a disincentive to clinical investigators. A comment period will extend until April 10.

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