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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.

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Addressing challenges of innovative cancer immunotherapy medicines

EMEA

EMA workshop to discuss treatments based on genetically modified T-cells. The European Medicines Agency’s ...

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FDA updates draft guidance on premarket safety notifications for dietary supplement industry

The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety ...

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FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

The U.S. Food and Drug Administration issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made ...

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Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of ...

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FDA approves first intraocular lens with extended range of vision for cataract patients

The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, ...

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FDA approves new medication for dry eye disease

The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of ...

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FDA approves Differin Gel 0.1% for over-the-counter use to treat acne

The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 ...

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FDA approves implantable device that changes the shape of the cornea to correct near vision

The U.S. Food and Drug Administration approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients ...

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FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe ...

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The role of single-arm trials in the authorisation of new cancer medicines

The European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) are co-organising a READ MORE

 


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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