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CDER officials say they want to hear from drug companies about their concerns, and what it would take to improve the program enough to get more volunteers. Read More
Sen. Elizabeth Warren (D-Mass.) called on former FDA Commissioner Scott Gottlieb to resign from his new seat on Pfizer’s board of directors — and claimed the “revolving door influence-peddling smacks of corruption.” Read More
CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation at the Drug Information Association’s annual meeting in San Diego last week. Read More
Nearly every state has opened investigations into whether the companies coordinated efforts to keep generic drug prices artificially — and illegally — high. Read More
Biosimilar companies are hamstrung by patent schemes, misguided legislation, rebate traps and other hurdles to market entry that have cost the U.S. healthcare system $7.6 billion since 2015, the Biosimilar Council claims in a new analysis. Read More