May. 4, 2014

In February of 2014 the FDA released a draft guidance document related to the development of drugs for analgesic indications. The importance of this document cannot be over emphasized in that it speaks to the current mindset of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products (DAAAP).

A multitude of topics are covered in it, including specific information regarding the following:

  • The development of new molecular entities versus reformulations
  • Requisite paths to specific analgesic indications
  • Early phase requirements
  • Appropriate endpoint selection
  • Recommended strategies for administration of rescue medication
  • Data imputation guidelines
  • Acceptable patient reported outcomes etc.

Warning: end() expects parameter 1 to be array, null given in /var/www/lotuscr.com/httpdocs/wp-content/themes/lotuscr/functionality/embed.php on line 95