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Question: According to US, What is the timeline for the sponsor to report an unexpected fatal or life threatening experience and follow up reports to regulatory authorities?

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Late-Breaking Information

Any important, new information received after the data base was frozen for review and report preparation may be presented in this section. Examples include significant new cases or important follow-up data. These new data should be taken into account in the Overall Safety Evaluation

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.

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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 new product to treat rare genetic disease

The U.S. Food and Drug Administration approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Hereditary angioedema, which is caused by having insufficient amounts of a plasma ...

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Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid ...

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FDA seeks permanent injunction against California pharmaceutical company

The U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its ...

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FDA approves Afrezza to treat diabetes

The U.S. Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within ...

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Regulator asks people to check their diabetes meters

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people with diabetes who use Accu-Chek® Mobile blood glucose meters to ensure they follow the important testing instructions. This is because the meter may give false high blood glucose readings if testing ...

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FDA issues guidance to support the responsible development of nanotechnology products

Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.

One final guidance addresses the agency’s overall approach for all products ...

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Producer of tainted dietary supplements sentenced in federal court

Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.

From at ...

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FDA approves Sivextro to treat skin infections

The U.S. Food and Drug Administration approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.

Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including ...

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Some Bee Pollen Weight Loss Products Are a Dangerous Scam

Products labeled to contain bee pollen that promise to help you lose weight or reshape your body could actually harm you, warns the Food and Drug Administration (FDA).

Bee pollen is the pollen that bees collect from flowers; it is the ...

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Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency

The European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.

This includes completing previously submitted information with additional data elements included in the new data-submission ...

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FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body

The U.S. Food and Drug Administration on June 13, 2014 approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in ...

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Opinion Poll

Trail sponsors are required to have insurance to cover compensation of trail subjects in the event of product related damage and also to indemnify investigators?
 
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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