Loading presentation...

Present Remotely

Send the link below via email or IM


Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.


FDA Drug Approval Process

No description

Hannah D

on 22 October 2012

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of FDA Drug Approval Process

The process of drug discovery to approval for public release takes 8 to 12 years and over $500 million. How are new drugs
developed and
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
most drugs
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.
Full transcript