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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Overview of FDA’s Expedited Development Programs.

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ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

ISPE

In regulated areas, information should always be validated and verified by a qualified healthcare professional before being used in patient care or treatment decisions. Writing assistant: Provided an idea of content to be produced, ChatGPT can create a complete paragraph, adding details and further information.