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FDA Pathways to Expedited Drug Approval

March 16, 2023

A profile of six major pathways to expedited approval of new drugs plus a deep dive into new legislative reforms that will create a fundamental shift in the Accelerated Approval pathway, bringing more transparency and accountability to the process.

Auditing to Ensure Manufacturing Quality: Predicting and Preventing Problems

March 7, 2023

This report covers the different types of audits and inspections and how to use them to improve quality. It describes the concept of a quality culture, its benefits and role in the company and how to build a quality culture.

Medical Device Pathways: Navigating FDA Roads to Market

February 7, 2023

This report discusses the FDA’s expectations regarding device risk and the role that risk categories play in determining the precise regulatory approval pathway. It explains the five pathways and how their requirements, benefits and challenges differ.

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

January 11, 2023

Developed by regulators and industry groups, the 34 efficacy guidelines in this manual represent the current global view of how clinical trials should be conducted to ensure they are safe and effective.

Orphan Drug Designation: Benefits and Challenges

December 8, 2022

This management report provides an insider’s view of the program designed to encourage you to research and develop treatments for rare diseases, making the investment of time and resources worth your while.

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

November 17, 2022

With the FDA and Department of Justice (DOJ) getting tougher on clinical data integrity, how confident are you that yours will withstand a thorough examination? This management report features insights and advice from three prominent regulatory and legal experts, two of whom are FDA veterans and all well-versed in both data integrity and the agencies’ priorities in enforcing it.

Best Practices in Pharmaceutical Process Validation

November 17, 2022

Will your SOPs and documentation withstand FDA scrutiny? This management report will help you establish validation procedures that pass muster. By taking a fresh look at the 2011 FDA guidance on process validation and applying it with a full lifecycle approach, you can stay compliant.