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Lawmakers are threatening the pharmaceutical industry’s reigning bad boy Martin Shkreli with a contempt citation if he fails to show up for next week’s hearing on drug prices. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding previous inspection findings and not living up to promises to carry out proper GMP practices for active pharmaceutical ingredients. Read More
With congressional efforts to pressure Gilead Sciences into lowering the price of two hepatitis C drugs floundering, members of the Senate Finance Committee are taking their concerns directly to the public. Read More
An international coalition of more than 80 pharmaceutical companies and trade organizations is calling on various governments to collaborate with industry to stamp out drug-resistant infections. Read More
CDER Director Janet Woodcock sees PDUFA reauthorization and beefing up staffing as two top priorities that will occupy much of the FDA’s time over the next year. Read More