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The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More
During the coming transfer of political power, the FDA will survive major changes despite strong rhetoric and vague promises for reform, said a long-time FDA insider. Read More
Gilead will have to pay Merck $2.5 billion for infringing a patent that covers the active ingredient of its blockbuster hepatitis C drugs, Salvadi and Harvoni, in the country’s largest ever judgment for an infringement. Read More
Spanish drugmaker Grifols is accused of defrauding the government of millions of dollars for promoting the use of its antithrombin drug, Thrombate III, in unapproved indications. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall batches of its drug products due to significant GMP deficiencies. Read More
Taking into account industry criticism, the FDA has loosened the data requirements that drugmakers will have to meet to determine the admissibility of imports entering the U.S. Read More