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Elaprase (idursulfase)
Elaprase (idursulfase) is a purified form of the lysosomal enzyme human iduronate-2-sulfatase of recombinant DNA origin. It is designed to replace the natural enzyme, increasing catabolism of certain accumulated glycosaminoglycans (GAG), which abnormally accumulate in multiple tissue types in patients with mucopolysaccharidosis II (MPS-II, or Hunter syndrome).Elaprase is specifically indicated for the treatment of Hunter syndrome in adults and children ages 5 and older. The drug has been shown to improve walking capacity in these subjects.
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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

FDA expands approved use of Imbruvica for chronic lymphocytic leukemia

The U.S. Food and Drug Administration expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received ...

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The United States and Mexico sign statement of intent to strengthen produce safety

The U.S. Food and Drug Administration and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the ...

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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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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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