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CDER’s Office of New Drugs established policies and procedures for review staff for the management of financial disclosure information submitted in NDAs, BLAs and supplemental applications. Read More
The maker of an over-the-counter sleep aid has been warned by the FDA for marketing and branding a product with a name that may cause consumers to confuse it with an older prescription drug no longer on the market. Read More
A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic for chronic heart failure as well as high blood pressure. Read More
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More
The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More