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keyword guidance

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

MAY 4, 2022

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. Image courtesy of qimono at pixabay.com.

FDA

FDA Documentation Communication

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

ISPE

JULY 10, 2023

Case 1: Creating Paragraphs from a Set of Keywords Authors: “Please provide a section about data integrity in computerized systems from a pharma quality assurance perspective in 100 words.” The Keyword. ChatGPT : “Data integrity in computerized systems is critical for ensuring the quality and safety of pharmaceutical products.

Labelling

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

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

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