On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...
GMP Consulting Supports FDA Audits, SOPs, Testing, and GMP Readiness for Supplement Manufacturers IRVINE, CA, UNITED ...
DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...
cGMP production of 186RNL targeted radiotherapeutic beginning in second half of 2022 to support ongoing and future ReSPECT™ clinical trials The FDA indicated agreement with the Company’s proposed ...
The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device ...
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
SINGAPORE, Jan. 5, 2026 /PRNewswire/ -- Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical's ...
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