Adverse drug reactions information requests

Safety update reports Reports that an NDA sponsor must submit to the FDA about new safety information that may affect the use for which the drug will be approved, or draft labeling statements about contraindications, warnings, precautions, and adverse reactions. Safety update reports are required 4 months after application is submitted, after the applicant receives an approval letter, and at other times upon FDA request. 

There are no accurate data that provide a comprehensive picture of the extent of healthy volunteer studies and hence of the incidence of adverse reactions. However, surveys and clinical series have been published from time to time. In 1984 the ABPI requested information from its member companies on their activities in this area. Of the 43 companies that responded, 28 conducted in-house studies and 41 commissioned external work. In the in-house studies, there were 18 671 subject exposures to drugs. There were no deaths or life-threatening suspected reactions. The incidence of serious suspected reactions that might have been attributable to drug was 0-27 per 1000 subject exposures. Of the 8733 subject exposures in external studies, there was one death on which the inquest reported an open verdict and no life-threatening suspected reactions. The incidence of suspected serious reactions was 0-91 per 1000 subject exposures. 

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