FDA Experiences Drop Box

The CPC wants to hear about your experiences dealing with FDA during the combination product review process. Have CDER’s requests conflicted with CDRH’s advice? Has CDER requested additional studies during or after the validation stage? Have the reviewing Centers refused to provide scientific explanations for their decisions? Tell us about it anonymously below.

Help the CPC notify FDA about areas of the combination product review process that must be improved.

How many combination products has your company submitted for FDA review in the past five (5) years? *
Does your company seek approval for its combination products outside the U.S.?
Which combination product type does your company primarily manufacture?
Describe a specific conflict or other issue with FDA you or your company has experienced in submitting a combination product for review:
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