OR WAIT null SECS
June 05, 2019
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
June 03, 2019
The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.
May 30, 2019
The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
May 15, 2019
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Empty and prefilled syringes must pass a range of quality control tests.
Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.
A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
May 02, 2019
Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.
The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.