Drugs

ICH Analytical Procedure Development Guidance

FDA has published the International Council for Harmonization (ICH) guidance, Q14 Analytical Procedure Development, describing science and risk-based approaches for developing and maintaining analytical procedures suitable for evaluating the quality of drug substances and drug products. The document says that the systematic approach suggested in other ICH guidances can also be applied to the development and life cycle management of analytical procedures.

“When developing an analytical procedure,” it says, “a minimal (also known as traditional) approach or elements of an enhanced approach can be applied.”

The guidance says it applies to analytical procedures used for release and stability testing of commercial drug substances and products, referred to as products. It can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach. The scientific principles described in the guidance can be applied in a phase-appropriate manner to analytical procedures used during clinical development.

The guidance contains an Introduction, General Considerations for Analytical Procedures, Analytical Target Profile, Knowledge and Risk Management in Analytical Procedure Development and Continual Improvement, Evaluation of Robustness and Parameter Ranges of Analytical Procedures, Analytical Procedure Control Strategy, Life Cycle Management and Postapproval Changes of Analytical Procedures, Development of Multivariate Analytical Procedures: Additional Considerations, Development of Analytical Procedures for Real Time Release Testing: Additional Considerations, Submission of Analytical Procedure-Related Information, Glossary, References, and an Appendix.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome