Regulatory Roundup: FDA Provides Online Course on its Drug-Regulation Activities - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: FDA Provides Online Course on its Drug-Regulation Activities

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration's website now features a free online 90-minute training program on the “Past, Present, and Future of FDA Human Drug Regulation.” The mini web-seminar provides an overview of the agency’s activities, starting with why FDA was established. The course includes a series of information slides, audio presentations, and brief polling questions. At the end of the session, users can take a test to receive a continuing education (CE) certificate or a certificate of completion (non-CE). The online course covers the steps required to develop and market a new drug (as well as OTC, generic, and fast-track drugs), the role of the Center for Drug Evaluation and Research, and the Office of Generic Drugs, patents and market exclusivity, compliance and postapproval monitoring, and recent FDA initiatives such as the Sentinel System, the Critical Path initiative, emergency relief, and harmonization. The goal is to help physicians, industry, patients, healthcare providers, and consumers better understand FDA and its activities.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here