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Q of the week

Q: What is informed consent?

Get the Answer: 

Metoprolol
Metoprolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins) and to treat angina (chest pain) and hypertension (high blood pressure). It is also used to treat or prevent heart attack.
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

First treatment recommended for rare bone disease

The European Medicines Agency (EMA) has recommended granting a marketing authorisation under exceptional circumstances for Strensiq (asfotase alfa), for the long-term treatment of hypophosphatasia, a rare inherited metabolic disorder affecting the bones, in patients who have developed the disease in childhood.

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First HDAC inhibitor for treatment of multiple myeloma recommended for approval in EU

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Farydak (panobinostat) for the treatment of multiple myeloma.

Farydak is the first cancer medicine that targets enzymes known as histone deacetylases or HDACs, which are involved in turning genes ...

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FDA approves new antiplatelet drug used during heart procedure

On 22 Jun 2015he U.S. Food and Drug Administration approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing ...

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Inexpensive generic heart disease drugs may treat Ebola

Generic drugs used to treat heart diseases also have the potential to bolster the immune systems of patients with Ebola virus and some other life-threatening illnesses, research has found.

Unlike other medications in development for Ebola, which attack the virus, statins and angiotensin ...

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New mandatory logo for selling medicines online

From 1 July anybody in the UK selling medicines online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of UK registered online retail sellers.

They also need to display on every ...

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FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance ...

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FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms

The U.S. Food and Drug Administration approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio ...

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Slim Fit capsules

Slim Fit capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Slim Fit capsules and found that:

the capsules contain ...

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Phase II human trial for Type-1 diabetes vaccine

The US Food and Drug Administration (FDA) has approved a phase II clinical trial for testing the ability of a promising vaccine to reverse advanced Type-1 diabetes, researchers said.

 

The generic vaccine called Bacillus Calmette-Guerin (BCG) was earlier found effective ...

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New treatment option for patients with advanced lung cancer

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Nivolumab BMS (nivolumab). Nivolumab BMS can be used to treat adult patients with a type of lung cancer called squamous non-small cell lung cancer (NSCLC), when the disease is ...

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FDA regulation to help ensure judicious use of antibiotics in food-producing animals

On 02 Jun 2015,the U.S. Food and Drug Administration announced the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these ...

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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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