During the development of an innovative healthcare product, early and effective communication with your regulatory agency is essential to achieve a complete and robust regulatory submission and streamline the review process. Generally, a company should consider interacting with the agency at certain stages of product development to exchange ideas on program status and planning (for example, before the initiation of a clinical trial or the submission of a marketing application*).1

Omissions of significant data in a regulatory submission may lead to the agency’s refusal to file the application, additional data being requested (that is, not achieving first-cycle approval), the submission not being approved or cleared by regulatory agency or the application being voluntarily withdrawn by the company.1

A collaborative effort to streamline product development

Product development should be a collaborative effort on the part of both the healthcare industry and the regulatory agency. Although the primary responsibility for product development (especially its identification, design and execution) lies with the healthcare industry, it is important to communicate the development plan to the regulatory agency and discuss any specific issues early on in the development phase. Such interactions allow critical issues to be discussed and resolved, bringing clarity to the agency’s expectations on submission requirements. Not facing these issues during the development phase will eventually lead to questions or the identification of deficiencies during the regulatory review process. Both these situations can entail significant remedial work and increaseyour time to market.1,2

Through early and open communication, regulatory agencies may help to:

  • Clarify the regulatory pathway for product development. This could include the classification of a medical device, the designation of a product type, the identification of eligibility for programs such as orphan drug designation or priority review, and so on.
  • Identify and interpret relevant acts, regulations, directives and other applicable statutes, guidance documents and recognized standards applicable and specific to your product. This helps to clarify the regulatory expectations in support of the regulatory application for your product.
  • Provide scientific and regulatory advice during product development that results in a more efficient and robust development program. This can ensure that the necessary types of studies and information are included in the regulatory submission, which helps to prevent deficiencies that could cause the agency to refuse to file the application or cause additional review cycles.
  • Provide advice regarding the study design that may affect the regulatory decision about submission approval. This advice may include helping you define adequate evidence of effectiveness (for example, end points, study design, patient populations), safety (sample size, dose response, assessment of drug-drug interactions, demographic differences) and quality (manufacturing procedures).
  • Discuss with the applicant any deficiencies that may occur at critical points of product development. This could include identifying potential filing and review issues that could be addressed before the application is submitted for review.3

Communications may occur via informal or formal means. Informal means may include telephone calls or e-mails for clarification of regulation rqeuirements. Formal means may include pre-submission meetings.

Did you know?

In the US, the Food and Drug Administration (FDA) has instituted a number of activities to provide technical and regulatory assistance to small manufacturers with the aim to help them to comply with FDA requirements. These activities include:

  • Holding meetings to hear the views and perspectives of small businesses
  • Conducting educational workshops (for example, FDA Small Business Regulatory Education for Industry [REdI])
  • Developing informational materials (for example, FDA/CDER Small Business Chronicles)
  • Providing channels through which small businesses can acquire information from the FDA3

For more information, visit the FDA’s Small Business Contacts page.

*Types of clinical trial applications may include:

  • IND = Investigational New Drug
  • CTA = Clinical trial application
  • IDE = Investigational Device Exemption

Types of marketing applications may include:

  • NDS = New Drug Submission
  • NDA = New Drug Application
  • BLA = Biologics License Application
    • MAA =  Marketing Authorization Application
    • PMA = Premarket Approval

Disclaimer

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.

Published: October 17, 2012

References

  1. U.S. Food and Drug Administration. (2005, April). Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products. Retrieved June 6, 2012, from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079748.pdf.
  2. Miller, L.L. & Cocchetto, D.M. (1997). The regulatory affairs professional in the “hot seat” in the drug development process. Drug Information Journal, 31, 805-23.
  3. U.S. Food and Drug Administration. (2009, June 18). Small Business Assistance. Retrieved August 22, 2012, from http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=small%20business%20assistance&utm_content=3.