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.
OTC monograph reform “remains a top priority” for the FDA, Lauren Silvis, chief of staff at the FDA’s Office of the Commissioner, said at a Consumer Healthcare Products Association meeting in Rockville, Maryland on Tuesday. Read More
Science has advanced enough that biosimilar sponsors can make a strong case for their product’s similarities to a reference product, but it’s going to be “critical” that sponsors understand the limits of their analytics, the FDA says in a new draft guidance document issued Tuesday. Read More
Three Republican back-benchers on Tuesday signaled their frustration with pharmacy benefit managers, with one asking whether the industry has become dominated by an unlawful monopoly. Read More
The U.S. District Court in Boston has ruled that a Dana-Farber Cancer Institute scientist and a former member of the Genetics Institute deserve credit as co-inventors of six valuable cancer immunotherapy patents. Read More
A key House subcommittee will take its turn grilling the drug industry Tuesday as it considers seven separate pieces of legislation that backers say would help reduce spiraling drug prices. Read More