Discovery & Approval
DRUG
Q & A
FDA agrees to grant you Fast Track Status for the development program.
FDA, Food and Drug Administration, is a federal agency of the United States Department of Health and Human Service. Fast Track program is designed for a drug that is “intended to treat a serious or life-threatening condition and non-clinical or clinical data demonstrate the potential to address unmet medical need OR a drug that has been designed as a qualified infectious disease products.” (FDA, 2014) Fast Track designation is submitted with IND or after and FDA has 60 days to review the request and make the decision. In this case, the Fast Track review is approved by FDA.
Try Me
Investigational New Drug (IND) is an application to the FDA to seek permission for a human clinical trial to be conducted. (Ng.R, 2003)
An IND application process follows FDA, 21 CFR (Code of Federal Regulations) Part 312. (Ng.R, 2003)
IND application discusses 3 main issues: (Ng.R, 2003)
(i) Animal Pharmacology and Toxicology Studies
(ii) Manufacturing Information
(iii) Clinical Protocols and Investigator Information
IND Application Submission
about 30 days
IND Application Process Flow Chart. (Ng.R, 2003)
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Ng, R. (2003) Regulatory Applications, in Drugs: From Discovery to Approval, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/0471722804.ch8
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FDA, 2014, ‘Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics’, May 2014, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), available from, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf