We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Generics industry groups told FDA officials during a June 15 public meeting that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018. Read More
The International Conference on Harmonisation has released a Q&A guide aimed at clarifying requirements for quality management, documentation, equipment cleaning and more in its Q7 guideline on GMPs for active pharmaceutical ingredients. Read More
India’s national drugs authority is planning to hire 147 inspectors this year to ensure adherence to good manufacturing practice standards, although proper training will prove essential for success, one observer says. Read More
The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said Thursday. Read More