Import alert on bulk glycerin: FDA calls for increased surveillance of glycerin from China in an Aug. 1 import alert issued after acetaminophen elixir manufactured using glycerin contaminated with diethylene glycol, an anti-freeze ingredient, poisoned and killed dozens of children in Haiti. Bulk glycerin from sources potentially relaying shipments from China also may be checked for the contaminant, the alert says. Glycerin is used in a number of products, including lozenges and suppositories, soaps, and moisturizer in cosmetics, the alert notes. No shipments of glycerin from China have been received in the U.S. this year, according to U.S. Customs Service data...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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 new pilot aims to take Brazil closer to ‘digital transformation.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
