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The guidance should strongly encourage sponsors to share “not only methods, practical aspects and results, but also subject-level data in a timely fashion,” Ionis said. Read More
The final rule defines the criteria the agency uses to determine which bulk drug substances will allowed for use in drug compounding operations. Read More
According to the report, the two WHO guidelines on treating severe pain “alarmingly” copy Purdue’s marketing strategies for increasing prescriptions and sales. Read More
America’s opioid crisis may be worsening—but there also may be a critical shortage of pain relief drugs, a government task force has concluded. Read More
A New Jersey generics maker pleaded guilty to price fixing and agreed to cooperate with an ongoing investigation into the generics industry, the Department of Justice announced Friday. Read More
CBD and THC are still regulated as prescription drugs and still illegal in food or supplements, but for now the FDA is going to focus on enforcement of false marketing claims, Acting Commissioner Ned Sharpless said Friday. Read More
The agency wants biosimilar sponsors to be ready for the 2019-2020 flu season and is urging sponsors to get their applications in by June 17. Read More
Working out of the firm’s Chevy Chase, Maryland office, Gottlieb will be involved as a full-time active investor across all the firm’s healthcare activities, with a focus on biopharmaceutical and healthcare services. Read More