The guidance outlines the FDA’s expectations of drug manufacturers in its Emerging Technology Program. The program encourages drug companies to engage early with the FDA so difficulties can be dealt with more quickly, ensuring faster resolution of challenges and a smoother path to approval.
The FDA issued final guidance aimed at providing drug companies with the criteria for involvement in the agency’s Emerging Technology Program. The initiative, launched by the regulator’s Center for Drug Evaluation and Research, seeks to promote innovation in drug manufacturing and product design. It is designed to give companies an avenue to present novel technologies to the FDA’s Emerging Technology Team before the regulatory submission process begins. This early access gives companies a chance to ask questions and submit proposals to quickly receive and act upon feedback from the regulator regarding investigational drug manufacturing technologies. Drugmakers’ meetings with the Emerging Technology Team will allow discussion of product or manufacturing design and development issues, as well as submission content associated with the emerging technology.
The FDA said its focus on drug manufacturing fits with its broader mandate to protect and promote public health, and also intends its efforts in innovative pharmaceutical manufacturing technologies to help prevent drug shortages. Participation in the program requires companies’ submissions to contain at least one technological element with which the FDA has limited experience. In addition, the program targets new or innovative technologies that could potentially boost a drug’s safety, identity, strength, quality or purity. The program’s Emerging Technology Team will partner with the Office of Compliance and Office of Regulatory Affairs to perform on-site evaluations and reviews, and make the final recommendations for approval submissions in the program.
In the final guidance, the FDA outlined three categories in which it would consider emerging pharmaceutical technologies:
- Small molecules, including continuous manufacturing (CM) of drug substances, CM of drug products, model-based control strategy for CM, continuous aseptic spray drying, 3D printing and ultra-long-acting oral formulations;
- Biological molecules, including controlled ice nucleation for lyophilization processes, advanced process controls, multi-attribute methods, next-generation sequencing, CM for upstream processes and small-manufacturing platforms for continuous bioprocesses (“pharmacy on demand”); and
- Multiple products, such as closed aseptic filling systems, isolators and robotic arms for aseptic filling, and novel container and closure systems for injectable products.
Applications to participate in the program should not exceed five pages, the regulator states in the guidance. The regulator also gave five criteria for requests from drugmakers looking to participate in the program, including:
- A brief description of the proposed emerging technology;
- A short explanation of why the technology is particularly novel and suitable for the program;
- A description of how the technology could improve product safety, identity, strength, quality or purity;
- A summary of the development plan and any potential barriers to implementation; and
- A timeline for a submission of an IND; original or supplemental ANDA, BLA or NDA; or drug master file (DMF) and its associated application.The addition of DMF is one of the few changes to the original 2015 draft guidance in the final guidance. The final guidance also specifies that products reviewed by the Center for Biologics Evaluation and Research are ineligible for the Emerging Technology Program.