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Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
The FDA hit CTX Lifesciences with a warning letter for several failures at its India-based drug manufacturing facility and the quality of its active pharmaceutical ingredients. Read More
PhRMA is urging the USPTO to reevaluate patent eligibility for prescription drugs to provide the drug industry a better framework for interpreting regulations and recent case law. Read More
Democratic members of Congress have asked President Trump how the federal hiring freeze will affect the FDA’s user fee program, which are set to be reauthorized later this year. They account for 42 percent of the agency’s budget. Read More
President Donald Trump hosted the leaders of PhRMA for a White House meeting on the state of the pharmaceutical industry and the FDA, saying that drug prices have been “astronomical” and pledging cuts to regulations. Read More
A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug. Read More