A Brief Guide to the FDA Drug Approval Process

A Brief Guide to the FDA Drug Approval Process Pre-Clinical DRUG DEVELOPED A sponsor develops a new drug compound and seeks to have it approved by the FDA for sale in the United States. Drug ANIMALS TESTED Developed A sponsor must test a new drug on animals for toxicity. Multiple species are What Systems used to gather basic information on the safety and efficacy of the compound are you using to being investigated and researched. manage your Animals Tested INVESTIGATIONAL NEW DRUG (IND) APPLICATION clinical trials? The sponsor submits an IND application to the FDA based on the results from the initial testing. The IND also includes a plan for testing the drug on humans. The FDA reviews the IND to assure that the proposed studies/clinical trials do not place human subjects at unreasonable CLINICAL DATA risk of harm. The FDA also verifies that Investigational New Drug (IND) Application there are adequate informed consent WAREHOUSING and human subject protection. 2. Clinical Phase I PHASE I Approximately 20-80 healthy volunteers Do you have a participate in a phase I clinical trial. This phase emphasizes safety and the goal is validated and to determine what the drug's most fre- quent side effects are and how the drug secure repository is metabolized and excreted. for your safety, clinical, Phase II Hundreds of patients participate in a phase Il clinical trial. This phase empha- PHASE II and non-clinical data? sizes effectiveness and the goal is to obtain preliminary data on whether the drug works in people who have a cer- tain disease or condition. For controlled clinical trials, patients receiving the Phase II drugs are compared to similar patients receiving a different treatment, usually a placebo or a different drug. Safety con- tinues to be evaluated and short-term side effects are studied. At the end of this phase, the FDA and sponsor discuss how large-scale studies in a phase III clinical trial will be conducted. Review PHASE III Meeting with FDA Thousands of patients participate in a ANALYTICS phase III clinical trial. The purpose of this phase is to gather more information about safety and effectiveness, study different populations and different dos- ages, and the use of the drug in combi- nation with other drugs. NDA NDA Review Application REVIEW MEETING The FDA meets with a sponsor prior to How are you the submission of a New Drug Applica- tion (NDA). detecting managing Application Reviewed NDA APPLICATION and The drug sponsor formally asks the FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human drug safety signals? data, the analyses of the data, as well as information about how the drug be- haves in the body and how it is manu- factured. Drug APPLICATION REVIEWED Labeling After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, the FDA review team is assigned to evaluate the sponsor's research on the Do you have drug's safety and effectiveness. fact-based DRUG LABELING Facility The FDA reviews the drug's professional Inspection labeling and assures appropriate infor- insight into your mation is communicated to healthcare professionals and consumers. ECLINICAL FACILITY INSPECTION clinical programs? The FDA inspects the facilities where the drug will be manufactured. DRUG APPROVAL Drug Approval The FDA will approve the application or issue a response letter. 4. Post-Marketing Phase IV PHASE IV Once the FDA approves a drug, the post-marketing stage begins. The spon- sor is required to submit periodic safety updates to the FDA. The objective of the updates is to monitor the serious adverse events related to the drug and take Have you considered action when necessary. Argus Safety to help manage your SAFETY AND PHARMACOVIGILANCE PV operations? Sources: www.fda.gov; www.oracle.com; www.fas.org; www.hhs.gov Learn how Oracle's clinical and pharmacovigilance applications can kelp your organization throughout the various olinical trial phases today! ABIOPHARM systemš Gold ORACLE Partner Partner with an Expert www.biopharm.com [email protected] +1 877 654 0033 (US) +44 (0) 1865 910200 (UK)