fda

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Clinical Research Solutions

The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

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Quality & Compliance

Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP

This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...

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Clinical Research Solutions

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...

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Clinical Research Solutions

2023: A New Chapter in FDA Drug Approvals - A Resurgence of Innovation

The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...

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Clinical Research Solutions

FDA’s Updated Software Guidance

The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...

Clinical Research Solutions

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...

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Clinical Research Solutions

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...

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Clinical Research Solutions

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...

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Clinical Research Solutions

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...

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Clinical Research Solutions

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...

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