ARTICLES BY ERIKA L. ROBERTS

• VR/XR In Drug Manufacturing: No Longer Sci-Fi

  8/13/2024

  Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.

• FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

  2/6/2024

  Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.

• FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology

  10/3/2023

  The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug–drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.

• 5 Promising Applications Of RNA Therapeutics

  7/28/2023

  Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.

• The Cancer Drug Shortage: When Quality Fails

  7/7/2023

  Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.

• Breeze Through Surprise Audits — Take These 5 Actions Now

  6/8/2023

  Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.