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The Association for Accessible Medicines (AAM) and its Biosimilars Council is urging the FDA to scrap its proposed suffix-based naming policy for biological products because it would act as “a barrier to biosimilars access.” Read More
Cancer drug sponsors won’t have to do separate studies if they can demonstrate that the weight of evidence shows that a given drug is dangerous to developing babies, the FDA says in a final guidance document issued Thursday. Read More
Rising public anger over drug prices has put the drug supply chain on borrowed time, a leading Republican Congressman warned industry executives on Thursday. Read More
“The number of clients whose data is known to have been copied represents approximately one percent of Charles River’s total number of clients,” the company said. Read More
The Department of Justice is offering drug companies on the receiving end of False Claims Act litigation a chance to walk away without crippling fines—as long as they disclose the fraud, cooperate with investigators and fix any underlying problems. Read More
The FDA may start accepting real-world evidence in support of drug applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said Wednesday. Read More