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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

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 Reasearch 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.

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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

Universal Flu Vaccine To End Annual Jabs

A vaccine that could end the need for annual winter flu injections by offering lifelong protection against all strains of the virus has been developed by scientists. The new universal flu vaccine, which researchers say will only need to be administered once, ...

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Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products.

The proposal of limiting of Acetaminophen (Paracetamol) in prescription combination products and giving Box Warning about its liver toxicity was considered by the DTAB in its 59th meeting held on 24th June, 2011 at New Delhi under the Chairmanship of Directorate General ...

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Malaria vaccine may have potential to save millions

 After more than 30 years of work, researchers have for the first time succeeded in creating a vaccine against malaria, a deadly disease that kills nearly 800,000 a year, most of them children. The work grew from a partnership that raises hope ...

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World's largest early clinical trials unit opens in UK

From The Christie’s Press Release: The cancer centre The Christie in Manchester, already leading across the globe for its research, today opens the world’s largest early clinical trials unit. It is housed in a newly completed £35 million three ...

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Corengi: Clinical Trial Search Engine for Type II Diabetes

From LocalHealthGuide: An online matching service, Corengi (Corengi stands for “Clinical Options Research Engine”), that helps patients with type II diabetes find research studies they might want to participate in through  finding the clinical trials that match their medical profile ...

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“Stem Cell Age” Begins in Clinical Research: World’s First Clinical Trial of Human Embryonic Stem Cell-Based Therapy starts

Human embryonic stem cell therapy is being tried on a human for the first time in a new clinical trial. This is the first clinical trial of its kind in the world. The first patient is reported as a patient in ...

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India’s Clinical Trial Registry to be updated with new software to provide data on deaths during clinical trials: First of its kind in Clinical Trial Registries

The clinical trial registry-India, run by the Indian Council of Medical Research, has seen an overwhelming response since registration was made mandatory in June 2009. But the existing software has not been able to handle all the information. To make the ...

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Investigator-Driven Clinical Trials (IDCT) in Europe: Fund, Trial, Treat

Professor Françoise Meunier, Director General of the European Organisation for Research and Treatment of Cancer, advocates the need for more academic research in the IDCT, wrote in Public Service Review: European Union - Issue 19. Every year, 3.2 million European ...

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US FDA issues final rule on safety information during clinical trials

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The new rule requires that certain safety information that previously had not been required ...

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EPA Report: Drugs and the Environment - Stewardship & Sustainability

Presented are the major insights, perspectives, and findings (over 40 in total) that have been gained from the body of work performed over the last 10 years at EPA's Office of Research and Development laboratory (Las Vegas, NV) on the topic ...

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US FDA will convene one-day public workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations

The US Food and Drug Administration (US FDA) will hold a one-day Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations on November 2, 2010 to facilitate an exchange of information about best practices in conducting cell and ...

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Opinion Poll

Which of the following general ethical issues to conduct 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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