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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in childre

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The health and safety of children is a top priority at the FDA, which is why we are requiring a series of changes to the labeling of two types of opioid medications in order ...

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FDA approves new drug to treat multiple sclerosis

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On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the ...

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Release of documents on two medicines temporarily halted

EMA’s appeals against interim ...

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FDA approves first treatment for frequent urination at night due to overproduction of urine

The U.S. Food and Drug Administration approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction ...

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Investigational drug shows promise for hard-to-treat renal cancer

The investigational compound savolitinib appears to have antitumor activity in patients with c-MET-driven papillary renal ...

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FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis

The U.S. Food and Drug Administration cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower ...

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Nine countries commit to halve maternal and newborn deaths in health facilities

On 14 Feb 2017 (Tuesday), 9 countries – Bangladesh, Cote d’Ivoire, Ethiopia, Ghana, India, Malawi, Nigeria, Tanzania and Uganda – committed to halving ...

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FDA approves drug to treat Duchenne muscular dystrophy

The U.S. Food and Drug Administration approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes ...

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FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

The U.S. Food and Drug Administration permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type ...

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FDA confirms elevated levels of belladonna in certain homeopathic teething products

The U.S. Food and Drug Administration announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The ...

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Clinical data for two more medicines now available online EMA updates industry guidance on submission of clinical data for publication

The European Medicines Agency (EMA) has published today clinical data for two additional medicines on its clinical data website, which now totals six ...

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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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