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Q: What is type 2 diabetes?

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Cost-benefit analysis
One of the tools used to carry out an economic evaluation. The costs and benefits are measured using the same monetary units (for example, pounds sterling) to see whether the benefits exceed the costs.
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 extends use of Promacta in young children with rare blood disorder

The U.S. Food and Drug Administration approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these ...

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FDA takes action against three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling

The U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as ...

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Updated guidance on good clinical practice released for consultation

Comments on the ICH E6 addendum are invited until 3 February 2016.The European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2)READ MORE

FDA approves first treatment for sexual desire disorder

On 18 Aug 2015, the U.S. Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

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Making IT services for medicine regulation in Europe more efficient

The European Medicines Agency (EMA) Management Board endorsed the European Union (EU) Telematics Strategy and Implementation Roadmap 2015-2017 on 6 August 2015 that had already been adopted by the Heads of Medicines ...

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Public-friendly information on herbal medicines now available

From now on the European Medicines Agency (EMA) will systematically publish summaries of the recommendations of its Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of a herbal substance in easy to understand, public-friendly language.

The ...

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FDA approves non-surgical temporary balloon device to treat obesity

The U.S. Food and Drug Administration approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works ...

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FDA approves diagnostic test to differentiate between types of HIV infection

The U.S. Food and Drug Administration approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.

Two major types of HIV ...

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Australian Public Assessment Reports for prescription medicines (AusPARs)

An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.

Before a prescription medicine can be made available in Australia, the company legally responsible for supplying ...

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FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

The U.S. Food and Drug Administration approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

Lung ...

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Companies sentenced for supplying hospitals with defective pre-filled syringes

A major healthcare company and a sister company have been sentenced for supplying hospitals with defective pre-filled syringes.

A major healthcare company and a sister company that sold a range of ready-to-use pharmaceutical products it manufactured have been ...

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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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