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Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD). Read More
The FDA rejected Adapt Pharma’s request to raise the standards for the approval of naloxone generics, arguing that products will be reviewed on a case by case basis. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
Generic approvals and rejections were little changed from November, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Read More
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
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