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A vaccine for a common — but deadly — infection of newborns, a new cancer treatment, and more promising data on an Alzheimer’s drug are among the stories we cover this month. Read More
Recommendations for study design to facilitate innovation in development of devices, such as deep brain, transcranial magnetic and spinal cord stimulations, intended to treat opioid use disorder (OUD) are the subject of a draft guidance issued July 27. Read More
AdvaMed and Deloitte have updated their 2017 report on assessing the value of diagnostic technologies by incorporating a look at how the shift of risk from payer to provider will affect the adoption of new medtech innovations — while at the same time, reducing cost, improving patient experience, outcomes and satisfaction. Read More
The FDA has issued a final guidance outlining a program that allows stakeholders to propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Read More
Helping consumers avoid adverse events from improper use of hydrogen peroxide-based contact lens care products (HPCP) by improving labeling is the aim of a final guidance the FDA released Wednesday. Read More
The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and economic value of Novartis’s drug iptacopan for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic blood disease. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
Drug-device combination products can pose cumbersome regulatory challenges for companies, say regulatory experts, primarily because the product has to comply with two complicated regulatory systems that are not designed to work together. Read More
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. Read More
The FDA has issued final guidance on assessment and control of DNA reactive impurities in harmony with guidance prepared by the International Council for Harmonisation (ICH). Read More
Astellas Pharma announced a $21.3 million research collaboration with PeptiDream to discover novel protein degraders — enzymes that disassemble and break down unneeded proteins — used in cancer treatments. Read More
CDRH has recognized low temperature vaporized hydrogen peroxide as an alternative to ethylene oxide (EtO) for medical device sterilization and is updating its reference documentation to assist manufacturers in making changes to sterilization procedures. Read More