Simpson, S., Chakrabarti, A., Robinson, D. et al. Navigating facilitated regulatory pathways during a disease X pandemic. npj Vaccines 5, 101 (2020). https://doi.org/10.1038/s41541-020-00249-5 Received 20 March 2020
FDA’s Fast Track is a program for products that have some initial evidence of efficacy or improved safety over an available therapy14. This designation provides an opportunity for frequent meetings and communication with the FDA. Most importantly, this program allows a “rolling review” process, in which the marketing application is submitted in pieces as each segment is completed rather than having to assemble the entire application and submit it all at once. This allows FDA to assess each segment as it is submitted, and thus FDA only must review the last segment when it is completed rather than the entire application.
Ino IR admitted that they should have obtained the Fast Track designation to expedite P2/3 IND OK.
FDA’s Breakthrough Designation15 is granted where a new candidate demonstrates substantial improvement over an available therapy on a clinically significant endpoint. Candidates demonstrating an improved safety profile over an available therapy with similar efficacy are also considered. Efficacy can be demonstrated using a pharmacodynamic biomarker, surrogate or intermediate clinical endpoint providing they strongly suggest a clinically meaningful effect. For example, Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine candidate and Janssen’s prophylactic vaccine for the prevention of respiratory syncytial virus both achieved breakthrough designation following a Phase 2 and 2b studies, respectively16,17. A breakthrough therapy designation enables fast-track designation, intensive guidance on a drug development program, and organizational commitment.
FDA’s Emergency Use Authorization (EUA) is enabled once the United States Secretary of Health and Human Services declares a specific national public health emergency41. It considers whether the “known and potential benefits of the product outweigh the known and potential risks” providing that no reasonable alternatives exist for treating the cause of the specified national public health emergency. Data to support the application may include domestic and/or foreign clinical trial data, in vivo animal data, and in vitro data that provide plausible support for clinical efficacy. Access to a product under an EUA is limited to the duration of the national health emergency and the specific access caveats imposed. Thereafter the product is again considered investigational. For example, during the 2009 H1N1 influenza outbreak, EUAs were granted for the dispensing of Tamiflu (oseltamivir phosphate) and Relenza (zanamivir), and intravenous Peramivir. These were discontinued in 2010 once H1N1 was no longer deemed a threat to the United States42. This pathway is applicable to medicines, biologics, vaccines, and medical devices, including in vitro diagnostics. So far, the EUA has been utilized primarily for diagnostic tests for several infectious agents including influenza, anthrax, coronaviruses, ebolavirus, and zika viruses.
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