The Natural Products Association launches the first industry-driven program designed to test the purity and composition of Chinese raw ingredients, the group announces July 21. Testing of raw materials by the U.S. Pharmacopeia's Shanghai, China laboratory "represents a significant departure from the current process where U.S. companies must rely on a test by Chinese laboratories or test samples themselves in the United States," NPA says. Benefits to this system include "reduced transit times and costs; greater traceability and documentation of ingredients used in the supply chain; use of state-of-the-art technology in testing; and a systematic approach to verification," NPA states. The association opened a branch office in China last July and began developing the program shortly after, preceding the spate of problems linked to contaminated food products shipped from China, NPA says (1"The Tan Sheet" July 24, 2006, p. 3 and 2"The Tan Sheet" July 16, 2007, p. 5). NPA launched the program because there "seemed to be a logical connection to have people on the ground" to monitor and maintain product quality and reliability since China is one of the biggest ingredient sources, NPA Vice President Scientific and Regulatory Affairs Daniel Fabricant told "The Tan Sheet"...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”