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FDA Drug Approval Process
Transcript of FDA Drug Approval Process
approved by the FDA? 1 out of 10,000 possible drugs are approved to be released
1 out of 3 drugs on the market recoup the manufacturer's development costs Drug development is a highly risky and
time-consuming process. Pre-Clinical Phase 1 to 2 years aka "Drug Development Phase" Thousands of compounds are
tested and developed to determine efficacy. Compounds are tested on animals (usually rodents) to determine
its safety at the effective dose. A potential drug must prove to be safe and effective before it can be submitted for FDA approval. The drug manufacturer files an
Investigational New Drug (IND)
application to the FDA. 6 to 12 months Clinical Phase Phase 1 Phase 1:
establishes dose levels
examines drug metabolism The drug is tested on
20 to 80 healthy volunteers. 1 year Phase 2 The drug is tested on 100 to 300
patients who have the disease Phase 2:
uses double blind studies
proves therapeutic usefulness
establishes dosing regimen & side effects It is the stage where
to advance. 1 to 2 years Phase 3 The drug is tested on thousands of patients. Phase 3:
compares new drug with similar drugs on the market
determines best dosage and interactions with other drugs 2 to 10 years The drug manufacturer files a New Drug Application (NDA) to the FDA. 6 to 12 months The drug is APPROVED for market release. Post-Marketing Phase aka Phase 4 3 years The manufacturer examines long-term effects of the drug.
They must make quarterly reports to FDA for 3 years. In rare cases, the drug is pulled from the market.
Physicians can report side effects. A few weeks after release, pharmacies receive shipments of the new drug. Doctors and nurse practitioners can prescribe
the new drug to their patients.