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GE Healthcare Urgent Field Safety Notice Healthcare Systems 9900 Innovation Drive Wauwatosa, WI 53226, USA GE Healthcare Ref: FMI 40837 2012-01-18 To: Managers of Nuclear Medicine Hospital Administrators.

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All studies falling into the category of Clinical Trials will require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA).

A to F – 0203 080 7166. G to L – 0203 080 6720. M to Z – 0203 080 7111.

ing to USA-92, the FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

FDA - Food and Drug Administration, USA Similarly to the MHRA in the UK, the FDA is the medical regulatory body in the USA and is responsible for the licensing of medications depending on their efficacy following clinical trials.

In the UK, a Clinical Trial Authorisation (CTA) from Medicine and Healthcare Products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (CTIMP) and for combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).

Medicines and Healthcare products Regulatory Agency. The adult clinical facilities at the WTCRF and RIECRF have been accredited under the Medicines and Healthcare Products Regulatory Agency (MHRA) Phase I Accreditation Scheme since July 2011. The paediatric facilities in our Children's CRF were accredited in 2015.

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

The MHRA may refuse authorisation if the clinical investigation does not meet the requirements of the regulation, the application is incomplete, the device or the Clinical Investigation Plan and Investigators Brochure do not correspond to state of scientific knowledge and do not provide evidence for safety, performance ...

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232