FDA readies advisory panel disclosure

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 meetings.

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

Read the full 975 word article

How to gain access

Continue reading with a
two-week free trial.