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 In this section:

                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)


                        Drug Development Tool (DDT) Qualification Programs
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          Development & Approval Process | Drugs
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)Development & Approval Process | Drugs Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)
  
  	
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    PrintThe Center for Drug Evaluation and Research, Office of New Drugs (CDER/OND) has launched the voluntary Pilot Program for the Review of Innovation and Modernization of Excipients (referred to as PRIME). PRIME is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations. This Pilot Program will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.

The Pilot Program will initially be available for novel excipients that (1) have not been previously used in FDA-approved drug products, and (2) do not have an established use in food.  It consists of two stages. The first stage is an initial proposal stage for excipient manufacturers to provide a high-level overview of their novel excipient. CDER intends to accept approximately four initial proposals but will consider accepting more proposals as resources allow. Excipient manufacturers whose initial proposals are accepted would then enter the second stage, during which they would provide a full data package consisting of toxicology and quality data.

Initial Proposals

At the initial proposal stage, excipient manufacturers will submit brief summaries describing the novel excipient, its proposed use, and the public health or drug development need addressed by the excipient. The initial proposal is anticipated to include a summary of the supportive data generated or collected so far and some indication of the timing of any subsequent data needed for submission of the Full Package. A link to the initial proposal model content outline can be found below under “Resources.”

FDA will review the initial proposals and select approximately four proposals (two for the first year and two for the second year) to proceed to stage two of the program. FDA will consider the following factors, among other considerations, in determining which proposals to select:

Potential public health benefit of the novel excipient (for example, excipients that may facilitate opioid abuse-deterrent formulations or excipients that may promote development of new therapies for serious and life-threatening diseases).
	Likelihood of the novel excipient manufacturer’s ability to submit a complete package within the established timeframe.
	Overall potential of the novel excipient to meaningfully improve pharmacokinetic characteristics that may lead to novel drug development.Initial proposals for the Pilot Program were accepted through December 7, 2021.

Selected Proposals

For novel excipients selected into the program, the developer should then submit a full package consisting of toxicology (see CDER Guidance for industry “Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients”) and quality data (chemistry, manufacturing, and controls data) similar to that provided in an investigational new drug application.

Resources

Proposal Model Content Outline

                                                                                  Content current as of:
      09/14/2022
              
              
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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