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The legislation, the Native Behavioral Health Access Improvement Act, would establish a behavioral health program to address the opioid crisis. Read More
Attorney General Jeff Sessions spoke in Lexington, Kentucky on Thursday, highlighting recently announced tools and programs geared towards fighting the U.S. opioid epidemic, including a team that will target online drug sales and a fraud detection unit. Read More
Under current quotas, 14 billion opioid doses reach the market annually — enough to prescribe a month’s worth for every adult in the country, according to co-sponsor Sen. Dick Durbin (D-Ill.). Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance. Read More
The FDA requested comments on planned modifications to its MedWatch system that will impact existing forms used to report adverse events, including FDA 3500, 3500A and 3500B. Read More
Representatives from the pharmaceutical and hospital industries agreed the 340B drug discount program needs reforms but disagreed as to what changes are needed in testimony before a Senate committee Thursday. Read More
The rule requiring advertisers to secure prior approval before referencing serious diseases will remain in place even after the pre-approval requirement is phased out. Read More