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Question:  What is the MHRA requirement for the outline of all active trials with the same investigational medicinal product (IMP)?

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Effexor XR (venlafaxin HCI)
Wyeth-Ayerst Laboratories received marketing clearance from the U.S. Food and Drug Administration for Effexor (R) XR (venlafaxine HCI) Extended-Release Capsules. This is a once-a-day treatment that relieves the symptoms of depression. Clinical trial results also showed that patients receiving Effexor XR for the treatment of depression experienced a reduction in anxiety symptoms. The most common side effects of Effexor included abnormal dreams, abnormal ejaculation, anorexia, dizziness, dry mouth, nausea, nervousness, somnolence, sweating and tremor.
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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.

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Clinical Research Today

Consultations on adoption of European Union guidelines in Australia

The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia.

Submission of comments

Your comments on the proposed adoption or non-adoption of ...

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FDA approves Ragwitek for short ragweed pollen allergies

On April 17, 2014, the U.S. Food and Drug Administration approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 ...

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FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules

The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed ...

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FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds

The U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a ...

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FDA approves Otezla to treat psoriatic arthritis

The U.S. Food and Drug Administration approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint ...

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MHRA issues warning about FreeStyle Blood Glucose Meter and FreeStyle Mini Blood Glucose Meter

The Medicines and Healthcare products Regulatory Agency (MHRA) advised people with diabetes about a fault in specific blood glucose meters that may potentially produce incorrect low blood glucose results.

The manufacturer, Abbott Diabetes Care, has recalled their FreeStyle Mini Blood Glucose ...

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FDA approves Impavido to treat tropical disease leishmaniasis

The U.S. Food and Drug Administration approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.

Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who ...

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FDA allows marketing of first medical device to prevent migraine headaches

The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

“Cefaly ...

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Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

AUDIENCE: Consumer, Dentistry, Emergency Medicine, Internal Medicine, Pharmacy, Pain Management, Surgery

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage ...

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FDA issues first orders to stop sale, distribution of tobacco products

The U.S. Food and Drug Administration issued orders  to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco ...

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FDA proposes updates to Nutrition Facts label on food packages

The U.S. Food and Drug Administration proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace ...

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Opinion Poll

Within how many days the progress report of an IND clinical trial needs to be submitted to FDA?
 
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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