Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry guidance Under…
Read more →Product Recalls Including Removals and Corrections
This guidance document is intended to provide guidance and recommendations to FDA-regulated industry regarding what information firms should give to the Food and Drug…
Read more →Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) guidance describes FDA’s compliance policy related to the retention…
Read more →Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s)…
Read more →Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs guidance is intended to assist applicants who are submitting abbreviated new drug…
Read more →In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs guidance is intended to assist applicants who are submitting abbreviated new drug…
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