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During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which it found 27 critical, 169 major and 155 minor findings. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
The FDA on Thursday blessed Merck’s Zepatier, a combination of elbasvir and grazoprevir, with or without ribavirin, for treatment of chronic hepatitis C virus genotypes 1 and 4. Read More
Massachusetts Attorney General Maura Healey is mulling legal action against Gilead Sciences over its sky-high prices for two hepatitis C medications, alleging that the company’s approach could violate the state’s antitrust laws. Read More
Would-be FDA Commissioner Robert Califf is facing another potential congressional hurdle, with Sen. Joe Manchin (D-W.Va.) saying he will filibuster the nominee, citing his strong ties to the pharmaceutical industry. Read More
The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee yesterday, pushing back against criticism that the FDA should tackle rising drug prices. Read More
The Office of Manufacturing Quality’s 2015 annual report of warning letters blasted the drugmakers for disregarding previous inspection findings. Read More
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to unnaturally extend the life of another medication. Read More