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Q of the week

According to HPFB (Canada), What is the retention period for essential documents?
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Cyanide poisoning
Cyanide poisoning is a fairly common disease of herbivorous animals, caused by eating cyanogenic plants containing glucosides that are hydrolyzed, yielding hydrocyanic acid; hydrogen cyanide and its salts are extremely poisonous to humans, either by inhalation or by ingestion.
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 first generic Copaxone to treat multiple sclerosis

On 16 Apr 2015, the U.S. Food and Drug Administration approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

Sandoz has received FDA approval to market generic glatiramer acetate ...

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FDA approves Corlanor to treat heart failure

On 15 Apr 2015,the U.S. Food and Drug Administration approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.

Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart ...

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WHO calls for increased transparency in medical research

WHO issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, ...

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FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme

On 13 Apr 2015, The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.

Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids ...

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European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) recommends updating advice on use of high dose ibuprofen

Review confirms small increased cardiovascular risk with daily doses at or above 2,400 mg

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a ...

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FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C.

The U.S. Food and Drug Administration is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., ...

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FDA approves breath test to aid in diagnosis of delayed gastric emptying

April 6, 2015, the U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.

Current tests used to diagnose gastroparesis typically involve the use of ...

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FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures

The U.S. Food and Drug Administration approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open ...

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FDA approves Cholbam to treat rare bile acid synthesis disorders

The U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with ...

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MHRA is 1 of 10 regulators to help with the development of treatments for dementia

Following a workshop with other international regulators, MHRA has published information on how we continue to support the development of drugs for dementia today.

The workshop, which took place in November 2014, was used to see how ...

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FDA releases final guidance on reprocessing of reusable medical devices

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.

The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers ...

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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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