Standardizing Data and Documentation for Streamlined Regulatory Review
In the fast-paced world of pharmaceutical and biotechnology, companies are constantly seeking ways to bring their products to market quickly and efficiently. To achieve this, it is essential that they work closely with regulatory agencies, providing clear and consistent information to support their submissions. This is where standardization of data and documentation comes into play.
Standardization of data and documentation is critical for improving the ease and efficiency of regulatory reviews. Industry groups such as CDISC and PHUSE have been at the forefront of this effort, providing data standards and accompanying documentation to help companies present their information in a clear and consistent manner.
CDISC has provided data standards for submissions of clinical and non-clinical data, while PHUSE has focused on the documentation accompanying the data. For clinical study analysis data, PHUSE worked with the FDA to develop the Analysis Data Reviewer’s Guide (ADRG) to assist regulatory agencies in understanding the analysis data for a single study.
However, there has been a gap in standardization when it comes to presenting pooled safety and efficacy data to regulatory agencies. Companies often provide this information in different formats, creating a need for standardization. The PHUSE Optimizing the Use of Data Standards (ODS) Working Group has taken on this challenge and is working to share a best practice for presenting pooled analysis data.
The standardization of data and documentation will help to streamline the regulatory review process, ensuring that all relevant information is presented in a clear and consistent manner. This will benefit both companies and regulatory agencies, making it easier for companies to bring their products to market and for regulatory agencies to assess their submissions.
In conclusion, standardization of data and documentation is a critical factor in streamlining the regulatory review process. Industry groups like CDISC and PHUSE are working to provide clear and consistent standards and guidelines, while the PHUSE Optimizing the Use of Data Standards Working Group is addressing the gap in standardization for presenting pooled analysis data. By working together, companies and regulatory agencies can improve the ease and efficiency of the review process, bringing new treatments and products to market faster.
