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.
To drive the development of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, harmonize EU regulations and exercise flexibility. Read More
Vermont Gov. Peter Shumlin signed into law Friday a transparency bill that would require certain drugmakers to justify their price increases for specific products. Read More
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The European Medicines Agency is offering drugmakers new advice on when to update risk management plans for products with centralized marketing authorization. Read More
The FDA is spelling out the criteria for expanded access to investigational drugs in three final guidances to make the process as clear as possible. Read More