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 […]
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 […]
M9 Biopharmaceutics Classification System Based Biowaivers
M9 Biopharmaceutics Classification System Based Biowaivers guidance is being provided by FDA. Two drug products containing the same drug substance or substances are considered bioequivalent if their bioavailabilities (rate and extent of drug absorption) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo […]
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), […]
Providing Regulatory Submissions in Electronic Format Standardized Study Data
Providing Regulatory Submissions in Electronic Format Standardized Study Data guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, […]