Government cuts red tape to revolutionise public services with cutting-edge tech
The government has announced it is slashing the red tape that holds back groundbreaking innovations from coming to market.
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MOLOOCO dba Ourlyard – Online Advisory Letter
MOLOOCO dba Ourlyard – Online Advisory Letter -
Guangxi Yulin Pharmaceutical Group Co. Ltd. – 710422 – 09/30/2025
CGMP/Finished Pharmaceuticals/Adulterated -
www.usmedschoice.com – 716055 – 10/06/2025
Unapproved New Drugs/Misbranded -
All American Wellness – 715991 – 09/09/2025
Compounding Pharmacy/Misbranded -
Foshan Yiying Hygiene Products Co., Ltd. – 715548 – 10/10/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Acme United Corporation – 712324 – 10/10/2025
CGMP/Finished Pharmaceuticals/Adulterated -
BRS Analytical Services, LLC – 711133 – 09/17/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Field Safety Notices: 13 to 17 October 2025
List of Field Safety Notices from 13 to 17 October 2025.
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BsUFA III: Fiscal Years 2023-2027
New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available. -
eCTD Submission Standards for eCTD v3.2.2 and Regional M1
eCTD Submission Standards -
eCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0