medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 11 Sept 2024 Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2024 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft This guidance is intended to assist sponsors…
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Mar 2024 FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Final The purpose of…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Sep 2023 Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”OCTOBER 2023 Source: FDA…
Date Title of guidance and link to document Type and level of guidance About the guidance 27 Jun 2023 Prohibition on Wholesaling Under Section 503B of the FD&C ActSource: FDA Draft Under section 503B of the FD&C Act (21 U.S.C.353b),…
Date Title of guidance and link to document Type and level of guidance About the guidance 31 Mar 2023 Identification of Medicinal Products — Implementation and Use Source: FDA Final This guidance is for sponsors, applicants, and registrants who are…
Title of guidance Type and level of guidance About the guidance Source E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers Final guidance The ICH E2C(R2) IWG has prepared this Q&A document to support implementation of the guidance in practice.…
Title of guidance Type and level of guidance About the guidance Source Providing Over-the-Counter Monograph Submissions in Electronic Format Draft This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act) (21 U.S.C. 355h)…