The FDA is enhancing transparency of their drug-approval process. They will use clinical trial information in order to support innovation and scientific inquiry with respect to new drugs.

The development and distribution of new medical technology is dependent on the exchange of information. This information relates to the decisions to undertake research, invest in scientific innovation and also prescribe and use certain treatments effectively. Ensuring the transparency of this information is vital for boosting the public health value of the resulting innovations.

The FDA are exploring new ways in which they can share information regarding product approvals. They hope to enhance transparency and improve patient care while better informing providers about the products they prescribe. One area in which the FDA are reviewing the information-release process is Clinical Study Reports (CSRs). These reports contain the bottom line information on the methods and results of a clinical trial for a new drug. Assessment of drug efficacy and safety uses this vital data.

The current drug approval process ensures that the FDA release the information used to review the New Drug Application (NDA). This includes:

  • Summaries of the product written by medical reviewers
  • Labelling proposals
  • Data supporting the safe and effective use of the product

However, the format of this information is complex. It creates problems for external reviewers when trying to extract clinical evidence that supported the FDA’s approval of the product.

Therefore, in an effort to resolve this issue, the FDA are proposing a pilot program that will assess whether public access to drug approval information is increased by disclosing information found within CSRs. The pilot program will select up to nine recently-approved NDAs. The programme will then publish the CSRs, that were submitted to the FDA for the approval process, for each.

It is expected that, by making the CSRs public, stakeholders will be provided with the clinical evidence information supporting an application. This will therefore increase transparency of the FDA’s drug-approval process.

What else are the FDA doing?

The FDA have also announced new efforts to increase access to information regarding the trials associated with new medical products.

The National Institutes of Health database registers a significant number of public and also privately supported clinical trials. Many of these trials relate to the research into new drugs. An application made to the FDA for approval of a new drug will use this research for its foundation. Currently, connecting a specific trial from the database to its FDA-related processes is extremely challenging.

The FDA therefore plan to include an identification number (NCT #) in their approval materials. This number will link that drug approval process to clinical trial information on the National Institutes of Health database. Patients, academics and scientists will all be able to use the NCT number to track clinical research, from a drug’s development through to the regulatory process.

To find out more about how the FDA are enhancing transparency of their work, please visit their website.

To learn how Perfctus Biomed can help to support the regulatory submission of your product, please visit our services page or alternatively, contact us.

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