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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
CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. 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
Six compounders are suing Express Scripts, accusing the nation’s largest PBM of participating in a massive conspiracy to put independent compounders out of business. Read More
GlaxoSmithKline said it plans to improve its data protection policies in the wake of a federal indictment in Philadelphia this week accusing two former researchers of plotting to steal trade secrets for possible sale to China. Read More