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                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


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          Development & Approval Process | Drugs
          Clinical Data Summary Pilot ProgramDevelopment & Approval Process | Drugs Clinical Data Summary Pilot Program
  
  	
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The Center for Drug Evaluation and Research (CDER) is committed to improving efficiency and transparency in the drug approval process. Consistent with this goal, in 2018 CDER launched a pilot program to assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions. The pilot program was open to up to nine new drug applications (NDAs).  CDER planned to release portions of the clinical study reports (CSRs) from the sponsor’s NDA along with the action package following approval. The CSRs are made up of summaries of clinical information used in making market approval decisions, and were included in the information posted at the drug’s entry at Drugs@FDA.

CDER’s goal was to provide a usable summary of clinical evidence.  During the pilot FDA gathered feedback about how useful posting portions of CSRs of the summary data in this format might be for the drug research and development community, medical researchers, and the public.

**Clinical Study Reports**

Erleada**Update [03/26/2020]**

After receiving very useful, internal and external, knowledge and feedback as part of the pilot program, FDA has decided to conclude the pilot. Although the pilot is ending, given the interest in increasing transparency in the drug approval process, the agency has gathered many lessons learned that we will apply to future efforts. For example, the agency found that there are significant inefficiencies in having multiregional disclosure requirements relating to often identical clinical data summaries. These inefficiencies multiply the transactional, administrative, and redaction (because there are differing regional disclosure standards) costs, whether the costs are incurred by industry or the regional regulatory authority. These costs create barriers to programs to disclose clinical trial information which might be reduced if a multiregional/centralized or regional approach could be achieved.

Through the pilot, the agency also identified a potential approach that could facilitate a harmonized system for disclosing study reports, if legal and regulatory barriers could be removed. The general framework of this approach can be found in this FDA Statement.

**Update [6/26/2019]**

The recruitment phase of the pilot has now concluded. Throughout this process, FDA has gathered valuable information and remains committed to providing a usable summary of clinical evidence. As we move into our evaluation phase, FDA has published a federal register notice seeking feedback on the pilot.

We are also gathering feedback on another effort that also seeks to provide greater clarity on FDA’s application review and decision-making process. This new integrated review process and template developed under the New Drugs Regulatory Program Modernization, which is part of a multi-year, multi-phase effort to enhance the new drugs regulatory program, are intended to promote more integrated and interdisciplinary assessments, enhance clarity of our assessments regarding the benefits and risks for new drug products, and improve our communication about the basis for new drug approvals. FDA believes this program will also meet the goal of effectively communicating the basis for new drug approvals. The Agency is therefore considering whether to focus its efforts to better communicate the basis for drug approvals on the development of new integrated review documents, rather than on the release of CSRs. The Agency looks forward to stakeholders’ thoughts about these programs so that we can continue to provide information that is clear and transparent.

Additional Information

FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes
	March 26, 2020
	Federal register notice: New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication; Notice; Request for Comments
	June 26, 2019
	FDA-in-Brief: FDA seeks public feedback on new drug approval transparency efforts
	June 26, 2019
	FDA's Clinical Data Summary Pilot Program: Questions Frequently Asked by Industry
	May 2, 2018
	FDA Voice Blog: FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals 
	March 19, 2018
	FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs 
	January 16, 2018

                                                                                  Content current as of:
      03/26/2020
              
              
Regulated Product(s)
		 DrugsDevelopment & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
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