The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

美国FDA正式发布《质量管理体系法规》（Quality Management System Regulation, QMSR）最终规则，标志着运行了近30年的质量体系法规（QSR, 21 CFR Part 820）即将被全面修订。 这项被称为 FDA ...

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...

FDA draft guidance backs alternatives to animal testing in early drug development, outlining validation for new approach methodologies like simulations. Read more here.

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...

An analysis of internal Food and Drug Administration documents by researchers at the Johns Hopkins Bloomberg School of Public Health finds that the agency generally followed cautious and ...

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...