Best of August: Top 5 Insights In Drug Formulation and Delivery

#1 - Bacterial Endotoxin Testing, Part 1: Overview

All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

#2 - Oral Peptide Delivery with Protagonist Therapeutics' Dinesh Patel

In this inaugural episode of Sit and Deliver, host Tom von Gunden invites Dinesh Patel, president and CEO at clinical stage biotech Protagonist Therapeutics, to deliver the rationale for targeting I&I diseases and other therapeutic areas with oral peptides.

#3 - FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

#4 - A Closer Look: The Impact Of PFAS Regulations On The Medical Device Industry

By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

#5 - Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail

In Part 1 of a two-part series, Fran DeGrazio explains why biopharma companies should build and apply best practices in advance of official regulations regarding drug product quality.