Science & Technology

Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here).  The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products.  The document provides guidance for NDA holders (for new products or […]

  Thanks for reading our blog this year, We write them with feeling and lots of cheer. With GDUFA, QbD, and OPQ to understand, Our team searched for news from throughout the regulated land. The year 2105 went by so quick, Picking the best blog topics was really the trick. We hope you have gained […]

FDA approved the first genetically engineered fish which they have determined is safe for our food supply. The fish is engineered to grow faster, which will, of course, make it a more abundant food source. Who knew a fish could be approved through a new animal drug application (NADA)? Not me!

  Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here)  which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”. The new Guidance covers the required information relating to […]

Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.” The document outlines the FDA’s thinking on the use of quality metrics data “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”

The buzz about abuse-deterrent opioids (no pun intended) in some camps seems to view these products as a panacea for the prescription drug abuse problem. In my view, that is far from the reality of the problem and clearly miles from the solution.