By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    An Expert’s Guide To Building and Improving Endurance
    June 30, 2022
    medical assistants
    What Do Medical Assistants Do On a Day to Day Basis?
    April 5, 2022
    superfoods to help with prostate health
    10 Healthy Foods That Can Help Protect Your Prostate
    August 29, 2022
    Latest News
    Health Benefits of Taking a Vacation to Reduce Your Stress
    September 27, 2023
    First Aid Training Enhancing Workplace Health and Safety
    September 25, 2023
    Beyond the Clinic: Medical Surveys Are a Roadmap to Passive Income for Doctors
    September 23, 2023
    5 Self-Care Habits to Help You Live an A+ Life
    September 21, 2023
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Patient Engagement Solutions – Your Smart Health Software
    February 15, 2018
    The Real Cost of Data Breaches
    March 19, 2015
    Emerging Diabetes Technology Promises to Make Life Easier
    July 22, 2018
    Latest News
    Job Seekers with Disabilities Should at Health Insurance Benefits
    September 12, 2023
    Reasons That Drug Prices Are Rising to Unsustainable Levels
    September 12, 2023
    How Revenue Lifecycle Management Helps Healthcare Providers to Optimize Business Operations
    September 6, 2023
    The Hidden Benefits of Practice Exams for Medical Professionals
    September 6, 2023
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Overview of the FDA Approval Process
Share
Sign In
Notification Show More
Aa
Health Works CollectiveHealth Works Collective
Aa
Search
Have an existing account? Sign In
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > Public Health > Overview of the FDA Approval Process
Policy & LawPublic Health

Overview of the FDA Approval Process

Chris Visser
Last updated: 2021/02/05 at 8:37 AM
Chris Visser
Share
5 Min Read
SHARE

The Food and Drug Administration (FDA) is the U.S. regulatory agency responsible for approving new drugs. The FDA has very strict regulatory requirements that all pharmaceutical companies must abide by. Here are some things that you should know about the FDA.

Contents
Stages of the FDA approval processWhat does the FDA approval process mean for drug companies?

Stages of the FDA approval process

There are multiple stages of the FDA approval process. Pre-clinical trials The FDA will not allow drug companies to test their products on humans without having data showing they are safe first. The first step is to test the drugs on animals. They must show detailed findings on the side effects and prevalence of any problems they find. They should also demonstrate the overall effectiveness of their drugs if any animals had one of the conditions. Testing on healthy humans After satisfying the requirements of the pre-clinical trials, the drug manufacturer may test the drug on healthy humans. The subjects in this stage don’t have the disease, so the drug company isn’t trying to determine the effectiveness of the treatment. They need to complete this stage to show that the drug is at least safe. They must identify any side effects and safe dosage limits. Between 20 and 80 volunteers participate in this stage. Depending on the severity of these problems, they may need to be addressed in future stages. If the drug is deemed unsafe at this stage, the FDA will pull it. Testing the drug on people that have the disease Once the FDA is satisfied that the drug is safe, the drug company can begin testing it on patients that have the disease. The drug company will use both a sample and control group. The sample group is given the CBD capsules or other medication, while the control group is given a placebo. The goal at this stage of the process is to determine whether or not the medication is a viable treatment. Several hundred patients participate in this stage of the testing process, because the drug company needs a large sample to determine effectiveness with a reasonable level of statistical significance. Meeting the FDA threshold at this stage is difficult. Fewer than one out of three drugs are approved for the third stage of testing. Testing on a larger sample of patients After passing the second stage, the FDA requires drug manufacturers to test their drug on a much larger sample size. Thousands of subjects are used in the final stage. In addition to testing their drug with a larger population, the manufacture must look for data on different populations. They try to have a randomized sample, so they can determine the impact the medication has on patients of different genders, races, ages and Comorbid health conditions. Submit a new drug application After collecting their data and meeting FDA requirements in previous stages, drug companies may apply for a new drug application with the FDA. After the application is processed, the FDA gives them a small window of opportunity to make a decision. The company usually has 10 months to make their decision. However, in some cases they will only have six months. At this stage, the FDA will either approve the drug or require the company to rectify any problems. If the company intends to fix the problems, they may resubmit an application for approval.

What does the FDA approval process mean for drug companies?

Only one out of 10 drugs are approved by the FDA. Companies often spend hundreds of millions of dollars on medications that are abandoned during the early stages of the approval process. The average cost to develop a drug that meets FDA guidelines is over $2 billion. The approval process arguably plays a role in driving up drug prices, because manufacturers must conduct a lot of research to satisfy the FDA requirements and fix any problems. However, these regulations also play in important role in ensuring patient safety.

Sign Up For Daily Newsletter

Be keep up! Get the latest breaking news delivered straight to your inbox.
By signing up, you agree to our Terms of Use and acknowledge the data practices in our Privacy Policy. You may unsubscribe at any time.
Chris Visser September 27, 2017
Share This Article
Facebook Twitter Copy Link Print
Share
Previous Article What You’ve Been Wanting To Know About Sleep Problems
Next Article 4 Important Ways Healthcare Technology Improves Your Patient Care

Stay Connected

1.5k Followers Like
4.5k Followers Follow
2.8k Followers Pin
136k Subscribers Subscribe

Latest News

Andropause hormonal decline
The Benefits of TRT for Andropause and Hormonal Decline
Wellness September 28, 2023
Cancer Prevention
The Importance of Lipoma Examination in Cancer Prevention
Cancer September 28, 2023
dental implant
Cost Analysis of Dental Implants in Australia
Dental health September 28, 2023
View,Of,Niagara,Falls,In,Autumn
Health Benefits of Taking a Vacation to Reduce Your Stress
Health September 27, 2023

You Might also Like

health insurance disability
Policy & Law

Job Seekers with Disabilities Should at Health Insurance Benefits

September 12, 2023
rising drug costs
Pharmaceuticals

Reasons That Drug Prices Are Rising to Unsustainable Levels

September 8, 2023
healthcare providers
Hospital Administration

How Revenue Lifecycle Management Helps Healthcare Providers to Optimize Business Operations

September 6, 2023
Medical Professionals exams
Medicare

The Hidden Benefits of Practice Exams for Medical Professionals

September 6, 2023
Subscribe

Subscribe to our newsletter to get our newest articles instantly!

Follow US
© 2008-2023 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Lost your password?