Q of the week

Question: For safety and efficacy of FDC, Is clinical trial mandatory? Or can we justify safety and efficacy of FDC by literature review?

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WORK-SHARING

This term describes any arrangement between FDA and state or local agencies in which the parties agree to assume a portion of the activities necessary to fulfill common responsibilities. These arrangements are usually with state agencies having regulatory responsibilities that are essentially the same as FDA's. Ideally, these arrangements should be formalized by written memoranda.

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

Regulator warns dentists about the dangers of buying and using counterfeit and unapproved dental equipment

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning dentists about the potential danger of buying and using counterfeit and unapproved dental equipment. This follows the seizure of over 12,000 different pieces of poor quality dental equipment imported into the UK ...

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FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic

The U.S. Food and Drug Administration approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda ...

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FDA approves Esbriet to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, ...

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, ...

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FDA permits marketing of urinary prosthesis device for women

The U.S. Food and Drug Administration allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC). 

IDC is ...

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FDA approves a new ultrasound imaging agent

The U.S. Food and Drug Administration approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.

Lumason is a contrast agent made up of gas-filled microbubbles (or microspheres) that ...

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FDA approves first combination pill to treat hepatitis C

The U.S. Food and Drug Administration approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved ...

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The FDA takes steps to strengthen cybersecurity of medical devices

To strengthen the safety of medical devices, the U.S. Food and Drug Administration finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of ...

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U.S. Marshals seize botanical substance kratom from southern California facility

U.S. Marshals at the request of the U.S. Food and Drug Administration seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California. 

Mitragyna speciosa, commonly known as kratom, is ...

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FDA clears glucose monitoring system for use in hospital critical care units

The U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for ...

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FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample

The U.S. Food and Drug Administration allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.

Yeast bloodstream ...

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Opinion Poll

Which organizations listed below would you say has the greatest responsibility in educating the public about 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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