Arun Mathew

Sep 12, 2024 | biosimilardevelopment.com | Jayet Moon |Arun Mathew |Mike Ulman |Anupreet Kaur

Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations. The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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.

Aug 30, 2024 | outsourcedpharma.com | Jayet Moon |Arun Mathew |Louis Garguilo |David Lyon

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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. In Defense Of The Full-Time Equivalent (FTE)"Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs.

Aug 14, 2024 | meddeviceonline.com | Jayet Moon |Arun Mathew

By Jayet Moon and Arun Mathew The FDA released a new draft guidance, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, in early July. It provides guidance to industry and FDA staff on the purpose and content of a risk management tool for usability, a use-related risk analysis (URRA), that has recently gained lot of currency with the FDA.

Aug 6, 2024 | medicalnewstoday.com | Arun Mathew

Aubagio is a brand-name oral tablet prescribed for relapsing forms of multiple sclerosis in adults. It contains the active ingredient teriflunomide. Aubagio is not safe to take during pregnancy. Keep reading for specific information about reproductive health and Aubagio. For an in-depth look at Aubagio, see this article. Taking Aubagio while you’re pregnant may cause major congenital anomalies (commonly known as birth defects). In fact, Aubagio has a boxed warning about the risk of fetal harm.

Jul 9, 2024 | meddeviceonline.com | Jayet Moon |Arun Mathew |Jessica Sanford |Jeff Phillips

Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | July 9, 2024 The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process. RFID For Med Devices: Identifying A PartnerRFID is increasingly being used in medical devices.