FDA issued guidance for industry September 2021

Title of guidanceType and level of guidanceAbout the guidanceWhat does the guidance not address ?Source
ICH Q12: Implementation Considerations for FDA-Regulated ProductsDraft, Level 1 revised guidance
This guidance should be read in conjunction with ICH Q12, which this guidance complements by clarifying how the ICH Q12 tools and enablers can be implemented within the U.S. regulatory
system.

These guidances apply to drug substances and drug products that are the subject of NDAs, BLAs, ANDAs, and supplements to these applications regulated by the (CDER) and CBER. They also apply to combination products with device constituent parts that are the subject of NDAs, BLAs, ANDAs, and supplements to these applications regulated by CDER and CBER.



FDA website
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for IndustryFinal, Level 1 guidanceFDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been
received and addressed by FDA during the COVID-19 public health emergency.

FDA intends to revise and update this guidance as appropriate to address new questions.
FDA website