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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
Despite the catastrophic damage a tornado caused to Pfizer’s colossal sterile injectable drug manufacturing plant and warehouse in Rocky Mount, N.C., last week, FDA Commissioner Robert Califf says he doesn’t expect “immediate significant impacts” on the supply chain. Read More
The FTC and HHS have teamed up on a campaign about the privacy and security risks associated with online tracking technologies integrated into mobile health apps and websites with a letter to 130 hospital systems and telehealth providers. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 14 medicines for market authorization during its July meeting including GSK’s Apretude (cabotegravir) for HIV, seven cancer treatments and a drug for relapsing multiple sclerosis. Read More