thought leadership

FDA Regulatory Sciences

August 4, 2023

FDA Proposes New, Easy-to-Read Medication Guide for Patients

The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for...

FDA Regulatory Sciences

July 20, 2023

FDA's Concern over Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination

Recent contamination of several drug products in India resulting in fatalities have prompted a new FDA guidance entitled "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch...

Compliance FDA

April 22, 2023

The Importance of Responding to FDA 483 Observations

This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...

FDA Life Science Consulting

April 21, 2023

FDA Form 483: Common Pitfalls You Can Avoid

This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...

Quality & Compliance FDA

April 4, 2023

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

This article has been updated since its original publication date. Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have...

FDA Modernization of Cosmetics Regulation Act (MoCRA)

March 9, 2023

MoCRA 2022: Updated Requirements for Cosmetic Companies

MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...

FDA Rare Diseases

March 1, 2023

Challenges in Clinical Development of Products for Rare Disease

Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...

FDA North America

August 26, 2022

FDA Announces Availability of Multiple Draft Guidances - Drug Information Update

Today, FDA announced the availability of the following draft guidances for industry, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for...

FDA North America

August 25, 2022

FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’

FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’: On August 5, 2022, the U.S. Food and Drug Administration (FDA) designated ‘Empirically Based Bayesian Emax...