The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers ...

Maintaining a sterile cleanroom environment and stringent cleanroom protocols in biopharmaceutical manufacturing are critical to ensure optimal product quality and, ultimately, patient safety. With ...

Drugs produced by the New England Compounding Center were not put through the minimum procedures required to ensure sterility and were shipped to customers before the pharmacy’s own safety tests were ...