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FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”
Topics: New FDA Draft Guidance, clinicaltrials.gov
Since 2003 FDA staff has used a guidance document to satisfy (21 CFR 814.42(e)) which identifies the criteria for filing a Premarket Approval (PMA). While this guidance has served its purpose in helping provide a basis for FDA to accept or refuse a PMA, a new guidance was just released, “Acceptance and Filing review for Premarket Approval Applications” which FDA hopes will “clarify the criteria for accepting and filing a PMA, thereby enhancing the consistency of our acceptance and filing decision.”
Topics: New FDA Draft Guidance, Premarket Approval Applications, FDA