Drug Development Consulting

The Importance of Quality in Drug Development with Insights from the FDA Fiscal Year 2023 Report on the State of Pharmaceutical Quality

Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…

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Exploring Risk-Based Approaches to Raw Material Testing in Pharmaceutical Manufacturing

In the rapidly evolving pharmaceutical industry, the quality and safety of drug substances and products hinge significantly on the integrity of raw materials used in their manufacture. A risk-based approach to raw material testing and specification setting has emerged as…

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Empowering and Encouraging Innovation: The Advantages of the FDA’s Orphan Drug Designation for Drug Companies and Patients

It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since its passage in 1983, the Orphan Drug Act has helped countless individuals living with rare diseases receive access to life-saving…

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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager 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…

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Current Topics in Orphan Drug Development

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND…