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Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
Results from a recent open-label study showed that Pfizer’s antibiotic Zyvox increased the risk of death in patients with Gram-negative, catheter-related infections, according to an FDA MedWatch report issued March 16.
Drug manufacturers choosing to submit applications to CDER electronically — as opposed to on paper — will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, an FDA official said.
The draft “Safe Drug Compounding Act of 2007” would stop illegal mass manufacturing of drugs while allowing patients access to legally compounded medications, the Consumer Health Alliance for Safe Medications (CHASM) said.
FDA Commissioner Andrew von Eschenbach’s establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a “nice” idea but is not necessary for accomplishing the FDA’s mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
Fisher & Paykel Healthcare violated current good manufacturing practices by not documenting the assembly of its CosyCot radiant infant warmers and related accessories to guarantee that the devices meet product specifications, according to a recent FDA warning letter.
GlaxoSmithKline’s (GSK) kinase inhibitor Tykerb gained FDA approval for use in combination with Roche’s oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer — specifically in tumors that produce an excess of the HER2 protein.
The FDA needs to strengthen its regulation of direct-to-consumer (DTC) advertising after the agency took more than six months to cite a drugmaker for advertisements suggesting a sleep aid was indicated for use in children, Consumers Union said.