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The agency released a separate guidance listing approved countries for importing and batch testing medicines and manufacturing active substances. Read More
Twenty-eight percent of insulin manufacturers told Nevada’s state Department of Health and Human Services that they made no profit on insulin sales in 2017, according to the state’s first insulin price transparency report. Read More
The FDA issued final guidance for developers of drugs to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs), such as hemophilia and sickle cell disease. Read More
The FDA released two clinical-related guidances on Thursday for sponsors of drugs and biologics, on enrichment of clinical trials and on risk-based monitoring. Read More
The FDA hit two online entities with warning letters after discovering they sold combination packs of unapproved abortion pills over the internet. Read More
Pfizer will pay $975,000 to settle allegations by the state of Oregon that the drugmaker distributed misleading coupons and marketing materials in the state. Read More
HHS Secretary Alex Azar defended the administration’s fiscal 2020 budget proposal before a House Appropriations Committee subcommittee hearing Wednesday, citing “difficult choices” but underscoring the administration’s commitment to containing drug prices and tackling the opioid crisis. Read More
House Democrats on Wednesday took testimony on their bid to reform America’s drug prices with a hearing on seven bills that seek to promote generics. Read More