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Q of the week

Q: What are the practical benefits of comparative effectiveness research?

Get the Answer: 

Naltrexone

Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opiate effects (e.g., feelings of well-being, pain relief). It also decreases the desire to take opiates. This medication is also used to treat alcohol abuse.

Welcome to GCP HelpDesk Website 

In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations.  This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Research with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk   and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

Feedback
Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback  page and we appreciate your suggestion and comments.
 

Clinical Research Today

FDA approves new, targeted treatment for bladder cancer

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The U.S. Food and Drug Administration approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) ...

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Can regulators influence the affordability of medicines?

The growing problem of high medicine prices and its impact on the ...

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FDA issues rule for data collection of antimicrobial sales and distribution by animal species

The U.S. Food and Drug Administration finalized a rule today that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human ...

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TGA: Extension to suspension of Silimed medical devices (all - including breast implants)

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FDA issues rule for data collection of antimicrobial sales and distribution by animal species

The U.S. Food and Drug Administration finalized a rule today that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human ...

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FDA reminds health care professionals not to use drug products intended to be sterile from Medaus

The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The ...

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World's First Zika Virus Vaccine Made In India, Claim Scientists

HYDERABAD:  In an important "Make in India" moment, scientists at a Hyderabad lab say they have developed the world's first vaccine against the Zika Virus.

 

They say, in fact, that they have ...

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FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

FDA

The U.S. Food and Drug Administration announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public ...

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FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

USFDA

The U.S. Food and Drug Administration announced it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless ...

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Promoting high-quality clinical research to develop more and better medicines for children

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its 8th annual ...

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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

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The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox ...

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Opinion Poll

Which one of the following do you think is the most common reason for participating in 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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