TrainingDoyens

Toll Free: +1-888-300-8494 Login/Sign up

  • DigiMeet
    • About DigiMeet
    • Benefits
    • Upcoming DigiMeets
  • Webinars
    • Recorded Webinars
    • Webinar Packs
    • CEU Approved Webinars
    • Best Sellers
    • Training Catalogue
  • Annual Membership
  • Speakers
    • Our Experts
    • Speaking Opportunity
    • Ask a Question
    • Suggest a Topic
  • Corporate Offers
    • Corporate Training
    • Digital Marketing
    • Sponsored Webinar
    • GMP Consulting
    • IT Consulting
  • About Us
    • Company
    • Clients
    • Testimonials
    • Blog
    • Free Resources
    • Contact Us

    Training Doyens

    We provide comprehensive courses for all levels which are contemporary, simple and cost-effective with easy access and great delivery experience. Training Doyens is a multifaceted entity, an absolute knowledge repository. The work ethics of Training Doyens is to focus on individuals' productivity first and this to become a by-product of the teams' productivity.

Resources

Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.

Approved Drugs

Approved Drugs Life Sciences

Approved Drugs: Questions and Answers

1. How is a medicine approved by FDA?

Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends FDA's Center for Drug Evaluation and Research (CDER) the data from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Over-the-counter (OTC) drugs are regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

2. How can I find out if my medicine is approved by FDA?

To find out if your drug has been approved by FDA, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling. Drugs@FDA contains most of the drug products approved since 1939.

Source: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Training Doyens
26468 E Walker Dr,Aurora,
Colorado 80016-6104
Email: support@trainingdoyens.com
Toll Free:+1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

Our support team is available from
09:30 AM - 6:30PM Eastern
Monday to Friday


Connect with Us
QUICKLINKS
  • Webinars
  • About Us
  • Speakers
  • Terms & Conditions
  • Privacy Policy
  • Refund & Cancellation Policy
PAYMENT METHODS

We accept the following major credit/debit cards

payment options
GET HELP
  • Feedback
  • Support
  • FAQs
  • Site Map
  • Sponsorship and Advertising
  • Subscribe Newsletter
  • Unsubscribe
McAfee SECURE sites help keep you safe from identity theft, credit card fraud, spyware, spam, viruses and online scams
GET IN TOUCH WITH US

Copyright © 2017-2020 TrainingDoyens. All rights reserved.