Journal article looks at FDA draft guidance feedback
A piece of work that I took part in has recently been published in the journal Therapeutic Innovation and Regulatory Science. The article looks at the FDA draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug Device Combination Product Submitted in an ANDA”, which was published in 2017.
The article, entitled “An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products”, examines in detail the feedback that has been given to the FDA so far by a range of consultancies, pharmaceutical companies and industry consortia on the draft guidance. Overall it was felt that the guidance is certainly needed but there are issues within the draft guidance that need to be examined and addressed.
You can read more about it here: http://journals.sagepub.com/doi/pdf/10.1177/2168479018775659