Quality

EMA to Juggle Brexit and New Quality and Safety Guidelines

The European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines this year, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More

FDA Highlights ConOps Progress

ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More

EMA to Juggle Brexit and New Quality and Safety Guidelines Next Year

In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More

EMA to Juggle Brexit and New Quality and Safety Guidelines Next Year

In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More