We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Chelsea Therapeutics’ orphan blood-pressure drug Northera won FDA approval Tuesday, following a rocky review path that included two advisory panel nods and a complete response letter. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said Thursday. Read More
In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Sponsors of new drugs seeking marketing authorization in the EU must now apply to receive a numerical code unique to the application, the European Medicines Agency (EMA) said Tuesday. Read More
Three prominent Republican senators have added their voices to the growing number of critics attacking the FDA’s decision last year to approve Zogenix’s high-dose opioid Zohydro ER. Read More