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The FDA issued a warning letter to a Montana compounding pharmacy for insanitary conditions and significant violations of good manufacturing practices. Read More
Four Republican senators are urging Acting FDA Commissioner Ned Sharpless to expand the agency’s Parallel Track program to give patients with incurable diseases a chance at recovery. Read More
The World Health Organization on Tuesday adopted a drug price transparency resolution that critics have already lambasted as a sop to big pharma. Read More
Opening statements began on Tuesday in Oklahoma’s trial against Johnson & Johnson for the company’s alleged role in the opioid crisis—just two days after the state’s Attorney General Mike Hunter announced a settlement agreement with the other remaining defendant, Teva Pharmaceuticals, for $85 million. Read More
Requirements for acquiring written confirmations for importing active substances into the UK from EU and third countries won’t change—and UK drugmakers will still need to obtain them from the relevant issuing authorities in those countries. Read More
Members of both parties have been critical of benefits managers, with some condemning them as “middle-men” who needlessly drive up the cost of drugs. Read More
Ionis, Merck and Lundbeck offered feedback on the FDA’s guidance for developing natural history studies for rare disease drug development, praising some parts of the guidance but calling for more details. Read More