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Waxman-Hatch Act (1984 Drug Price Competition and Patent Term Restoration Act)

The 1984 Drug Price Act extended patent terms to account for the time it took a drug to receive FDA approval, and it reduced the barriers to entry for generic drug producers by allowing them to assert safety and efficacy based on information in the original NDA and on a proof that the original drug and generic drug are bioequivalent. The submission procedure for a generic drug is called an Abbreviated New Drug Application (ANDA).

Good Clinical Practice Guidelines for Clinical Research Coordinator, Principle Investigators

Mission

The aim of the GCP HelpDesk is to create “one-stop " platform for all the clinical research professionals, enquiring about any GCP related matters and encourage the practice of common, high-quality standards in all stages of clinical research throughout the world.

 

Objectives

  • To assist Physicians/Principal Investigators (PIs) in Clinical research on Good Clinical Practice (GCP) matters. Physicians/Principal Investigators and Clinical Research Coordinators (CRCs) are GCP HelpDesk´s main target users
  • To promote the highest standards for Good Clinical Practice (GCP) in the world
  • To promote GCP education and awareness

What does GCP HelpDesk offer?


Website
Detailed information on the GCP issues involved in Clinical Research and Drug Development, regulatory formalities/documents, FAQs, glossary, news and other Clinical Research resources.

 

HelpDesk
Personalized answers to your specific GCP-related queries, delivered by industry experts by e-mail.


FAQs


Latest news and events related to GCP


GCP focus Bulletin

Our journal on GCP with expert articles and practical sections, published quarterly.

 

Forum

 
 


Opinion Poll

Which organizations listed below would you say has the greatest responsibility in educating the public about clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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