Isotretinoin prescribing requirements updated with revised risk-minimisation measures
The updated safety measures will strengthen the MHRA’s ability to monitor safe prescribing while supporting patient access to treatment across all age groups.
-
-
Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.
-
C3TI Compass (Knowledge Repository)
Centralized knowledge repository for clinical trial innovation -
Joinn Laboratories Co. Ltd. – 09/20/2013
Joinn Laboratories Co. Ltd. – 09/20/2013. Country: China. Record Type: 483 -
Nubratori, Inc. Torrance, CA. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Nubratori, Inc. Torrance, CA. 483 issued 12/11/2025
FEI Number 3010166491
Firm Name Nubratori, Inc.
Record Type 483
State CA
Establishment Type Outsourcing Facility -
Products Claiming to “Cure” Cancer Are a Cruel Deception
Many ads on social media and “healthy” websites claim their products can cure cancer. They cannot. -
Petscript Inc. Paris, TX. 483 issued 09/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/18/2025
Short Title (70 char) Petscript Inc. Paris, TX. 483 issued 09/18/2025
FEI Number 3010282564
Firm Name Petscript Inc
Record Type 483
State TX
Establishment Type Producer of Sterile and Non-sterile -
Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
FEI Number 3010943533
Firm Name Pine Pharmaceuticals LLC
Record Type 483
State NY
Establishment Type -
Field Safety Notices: 12 to 16 January 2026
List of Field Safety Notices from 12 to 16 January 2026.
-
Clinical Outcome Assessment (COA): Frequently Asked Questions
Clinical Outcome Assessments (COA) Frequently Asked Questions -
Asahi Kasei Finechem Co., Ltd. – 11/14/2025
Asahi Kasei Finechem Co., Ltd. – 11/14/2025. Country: Japan. Record Type: 483 -
Sato Pharmaceutical Co., Ltd. – 11/21/2025
Sato Pharmaceutical Co., Ltd. – 11/21/2025. Country: Japan. Record Type: 483