Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form. The specifications apply to electronic submission of ICSRs for drug and biological products, studied under an investigational new drug application (IND); ICSRs from bioavailability/bioequivalence (BA/BE) studies conducted without […]
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 section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration […]
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 Administration (FDA) and how they should notify their customers about product recalls. This guidance is intended to assist those members of industry regulated by the FDA in handling most aspects of […]
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 of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study. Specifically, this guidance: • Addresses […]
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) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users.1 This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) […]
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 17 applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called 19 topical products.2 Because of the complex route […]
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 applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called topical products.2 Because of the complex route of delivery associated […]
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called “topical products.”2 Because of the complex route of delivery associated […]