Templates 
FDA Drug Approval
FDA Drug Approval
FDA Drug Approval
The FDA has a complex process for bringing a new drug compound to market – this gives a high level overview of that process from start to finish.
FDA Drug Approval
This diagram was created on Dec 28, 2020 12:55 PM and was last updated Mar 8, 2021 9:36 AM.
2.
Drug Development
Drug Development
Drug sponsor develops a new drug compound and seeks to have it approved by FDA for sale in the United States,.
Linked from1. New Drug Approval Process (Start)
Links to3. Animals Tested
3.
Animals Tested
Animals Tested
Sponsor must test new drug on animals for toxicity. Multiple species are used to gather basic information on the safety and efficacy of the compound being investigated / researched.
Linked from2. Drug Development
Links to4. IND Application
4.
IND Application
IND Application
The sponsor submits an Investigational New Drug (IND) application to FDA based on the results from the initial testing that include, the drug's composition and manufacturing, and develops a plan for testing the drug on humans.
Linked from3. Animals Tested
Links to5. (Report)
5.
(Report)
(Report)
Investigational New Drug (IND) application for review by the FDA
Linked from4. IND Application
Links to6. IND Review
6.
IND Review
IND Review
FDA reviews the IND to assure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. FDA also verifies that there are adequate informed consent and human subject protections.
Linked from5. (Report)
Links to7. Clinical Drug Trials
7.
Clinical Drug Trials
Clinical Drug Trials
IND application is approved to begin clinical drug trials.
Linked from6. IND Review
Links to8. Phase I (20-80 participants)
8.
Phase I (20-80 participants)
Phase I (20-80 participants)
The typical number of healthy volunteers used in Phase 1; this phase emphasizes safety. The goal here in this phase is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted.
Linked from7. Clinical Drug Trials
9.
Phase II (100's of participants)
Phase II (100's of participants)
The typical number of patients used in Phase 2; this phase emphasizes effectiveness. This goal is to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment—usually a placebo, or a different drug. Safety continues to be evaluated, and short-term side effects are studied.
Linked from8. Phase I (20-80 participants)
Links to10. Phase III Trial Planning
10.
Phase III Trial Planning
Phase III Trial Planning
Your meeting's description here...
Linked from9. Phase II (100's of participants)
11.
Phase III (1000's of participants)
Phase III (1000's of participants)
The typical number of patients used in Phase 3. These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs.
Linked from11. Phase III (1000's of participants)and 1 more
Links to12. Review Meetingand 1 more
12.
Review Meeting
Review Meeting
FDA meets with a drug sponsor prior to submission of a New Drug Application.
Linked from11. Phase III (1000's of participants)
Links to13. NDA Application
13.
NDA Application
NDA Application
The drug sponsor formally asks FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.
Linked from12. Review Meeting
Links to14. Application Review
14.
Application Review
Application Review
Your task's description here...
Linked from13. NDA Application
Links to15. Application Review
15.
Application Review
Application Review
After an NDA is received, FDA has 60 days to decide whether to file it so it can be reviewed. If FDA files the NDA, the FDA Review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.
Linked from14. Application Review
Links to16. Drug Labeling
16.
Drug Labeling
Drug Labeling
FDA reviews the drug’s professional labeling and assures appropriate information is communicated to health care professionals and consumers.
Linked from15. Application Review
Links to17. Facility Inspection
17.
Facility Inspection
Facility Inspection
FDA inspects the facilities where the drug will be manufactured.
Linked from16. Drug Labeling
Links to19. Drug Approval
19.
Drug Approval
Drug Approval
FDA reviewers will approve the application or issue a response letter. Note: The Accelerated Approval program allows earlier approval of drugs that treat serious diseases and that fill an unmet medical need. The approval is faster because FDA can base the drug’s effectiveness on a “surrogate endpoint,” such as a blood test or X-ray result, rather than waiting for results from a clinical trial. The Fast Track program helps reduce the time for FDA’s review of products that treat serious or life-threatening diseases and those that have the potential to address an unmet medical need. Drug sponsors can submit portions of an application as the information becomes available (“rolling submission”) instead of having to wait until all information is available.
Linked from17. Facility Inspection
Links to20. FDA Drug Approval
21.
Post-Approval Risk Assessment System
Post-Approval Risk Assessment System
Your milestone's description here...
Linked from20. FDA Drug Approval
Links to22. Periodic Safety Reports to FDAand 1 more
22.
Periodic Safety Reports to FDA
Periodic Safety Reports to FDA
Once FDA approves a drug, the post-marketing monitoring stage begins. The sponsor (typically the manufacturer) is required to submit periodic safety updates to FDA.
Linked from21. Post-Approval Risk Assessment System
Links to23. Safety Reports
24.
Drug Distribution Channels
Drug Distribution Channels
Your task's description here...
Linked from21. Post-Approval Risk Assessment System
Links to25. Reports of Adverse Events
25.
Reports of Adverse Events
Reports of Adverse Events
FDA’s MedWatch voluntary system makes it easier for physicians and consumers to report adverse events. Usually, when important new risks are uncovered, the risks are added to the drug’s labeling and the public is informed of the new information through letters, public health advisories, and other education. In some cases, the use of the drug must be substantially limited. And in rare cases, the drug needs to be withdrawn from the market.
Linked from24. Drug Distribution Channels
