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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
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable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
In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read More
Senate Republicans unveiled their hotly anticipated version of a bill to replace the Affordable Care Act Thursday, which includes the repeal of a pharmaceutical industry tax. Read More