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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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Allegra (fexofenadine hydrochloride)
Allegra has been approved as a treatment for seasonal allergic rhinitis. The labeling of Allegra recommends dosing of one 60-mg capsule, twice daily. The recommended starting dose for subjects with decreased kidney function is 60 mg, once daily. Allegra is available by prescription only.
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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

150th Anniversary Edition of the British Pharmacopoeia published

The 150th Anniversary Edition of the British Pharmacopoeia (BP) has been published. The BP is the authoritative collection of medicinal standards used and referenced in over 100 countries. With the first edition of the BP published in 1864 and the origins of ...

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FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

The U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical ...

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2014 Ebola Outbreak in West Africa

Fast Facts

  • Ebola is the cause of a viral hemorrhagic fever disease.
  • Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.
  • Ebola does not pose a significant risk to the U.S. public.
  • Treatment: CDC ...

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FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It ...

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FDA approves new drug to treat a form of Gaucher disease

The U.S. Food and Drug Administration approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.

Gaucher disease occurs in people who do not produce enough of an enzyme called ...

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FDA approves Orbactiv to treat skin infections

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

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

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FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements

The U.S. Food and Drug Administration announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as ...

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FDA approves Jardiance to treat type 2 diabetes

The U.S. Food and Drug Administration approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Type 2 diabetes affects approximately 26 million people and accounts for more than 90 ...

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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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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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