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Beginning on June 16, whenever a drugmaker receives approval for a new drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
Baxter’s struggles with particulates continue, as the drugmaker Wednesday recalled a single lot of dialysis solution contaminated with mold after reports of adverse events. Read More
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More
Just three months after gaining new authority over compounders, the FDA is facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching its new role and retroactively applying a new federal law. Read More
The White House on Tuesday proposed increasing funding for the FDA in fiscal 2015 by 8 percent above fiscal 2014, and requested that $25 million be directed towards the agency’s expanded authority to inspect compounding pharmacies. Read More
The FDA is telling drugmakers not to file supplemental applications for minor postapproval manufacturing changes such as swapping excipient suppliers, moving a manufacturing process within a plant or removing coloring or flavoring ingredients from a drug. Read More
Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA handed distributor and positron emission tomography (PET) drugmaker Cardinal Health a Form 483 for failing to properly verify batch records. Read More