FDA issued guidance for industry – September 2021

Title of guidanceType and level of guidanceAbout the guidanceWhat does the guidance not address ?Source
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) Draft Level 2 revised guidance This draft guidance document revises the draft guidance for industry New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (December 2018) and retains Q.I.12.
This draft guidance does not include new Q&As or make changes to currently issued
draft or final Q&As. Additional information about the Q&A format for this draft guidance
document is provided in the Background section.

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
FDA website
Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry

Revision 2
Final, Level 1 guidance
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
FDA website
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health EmergencyFinalFDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. This document updates the guidance of the same title issued in January 2021.
The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.
FDA website