Monday, January 10, 2000
WASHINGTON - The FDA has moved to implement a new disclosure
policy that will provide the public with internet access to the briefing data
on a drug candidate's safety and efficacy prior to the start of advisory committee
The disclosures could have dramatic effects, providing the
investment community advance detailed information about the outcomes of clinical
trials, as well as early warnings of potential problems at committee meetings,
such as disputes between sponsors and the FDA over the interpretation of data.
In addition, the internet postings could become a new source of safety and efficacy
data to clinicians and the public.