Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Wednesday, July 31, 2019
FDA In Brief: FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.