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WHO Issues Guidance on Antibiotic Pollution Control

On September 3, 2025, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste management practices for antibiotic production, comes in anticipation of a High-Level Meeting on...

Clinical Research Solutions

What You Need to Know About CBER Pre-IND Meetings

The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...

Clinical Research Solutions

Meet the Expert: Sharon Charles

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Indications and efficacy assessments of the approved CAR-T cells

Clinical Research Solutions

CAR-T Cells: Challenges, Lessons Learned, and Guidance for the Clinical Development

It comes as no surprise to any pharmaceutical or biotech company that planning the clinical development of CAR-T cells is an extremely challenging endeavor: high efficacy is expected in each targeted...

Clinical Research Solutions

How to Comply with the Nitrosamine Regulations for Your New Drug Product Marketing Applications

Introduction: Are you in the development phase for your medicinal product? Have you assessed your manufacturing processes with respect to the requirements for investigating the potential presence of...

Clinical Research Solutions

USP and FDA Propose Updates to Good Storage and Distribution Practices

Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...

Clinical Research Solutions

Meet the Expert: Lucy Radley

Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...

Various graphs and charts explaining Bayesian Emax Models

Clinical Research Solutions

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...

Old photography medicine bottles.

Clinical Research Solutions

FDA Issues FY2021 Report on the State of Pharmaceutical Quality

FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research has published the fiscal year 2021...

Clinical Research Solutions

FDA Publishes Responses to Good Clinical Practice Inquiries

FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....

Hands working on a laptop.

Clinical Research Solutions

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Clinical Research Solutions

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

Regulatory Sciences

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

Healthcare worker showing a woman details on a tablet device.

Medical Information

What are Patient Support Programs?

Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

Clinical Research Solutions

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

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Regulatory Sciences

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

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