Sat, Aug 30, 2014, 1:35 AM EDT - U.S. Markets closed


% | $
Quotes you view appear here for quick access.

Heron Therapeutics, Inc. Message Board

  • sunlover792 sunlover792 Mar 28, 2013 4:21 PM Flag

    Question for the Board regarding Human Factors Validation Study

    The FDA has asked APPA to conduct a human factors validation study evaluating the usability of the APF530 syringe system. . . What kind ofstudy is this? How many participants are required?; and how long do such studies take?
    Finally, if the FDA had a concern about that why wasn't it raised when APPA submitted its second application last September;and also why didn't the FDA ask for a re-analysis of the existing Phase 3 data back in September 2012 as well. Comments appreeciated

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • This is an assessment of the human studies. You know how you read something on a label but can't quite figure out how to make it work. The FDA wants APPA to validate the directions of the labeling provides adequate info to actually operate the syringe. I don't believe it will require test subjects. Because don't give themselves shots. It requires that people who give the shots understand how to administer.

12.300.00(0.00%)Jan 22 3:59 PMEST

Trending Tickers

Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.