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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
The FDA has rejected Advanced Accelerator Applications’ candidate for the treatment neuroendocrine tumors in adults, requesting that the company submit new analyses and correct manufacturing deficiencies. Read More
Submissions of manufacturing establishment information (MEI) by manufacturers are about to be changed. A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs. Read More
The FDA finalized guidance in December on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency, trading partners and wholesale distributors. Read More