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Newsletter - April 14, 2022

FDA Wants Sponsors to Submit Diversity Recruitment Plans in INDs and IDEs

Despite more than 10 years of prodding the industry, most products approved by FDA are still based on clinical trials conducted mostly on Caucasian volunteers. In future, FDA will require that sponsors present a formal written plan to recruit underrepresented racial and ethnic populations in the US for pivotal trials...Read More

FDA Defines Complex and Non-Complex Drugs for Generics Development

Companies developing generic versions of complex drugs are eligible for enhanced support from the Office of Generic Drugs (OGD), mainly via pre-submission meetings under Generic Drugs User Fee Act (GDUFA) with the OGD reviewers to discuss bioequivalence testing requirements. However, FDA’s process for defining...Read More

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