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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
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
The FDA on Wednesday banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality. Read More
The FDA is asking sponsors of BLAs, NDAs, and ANDAs to justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules. Read More
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More
The studies evaluated the humanized monoclonal antibody in patients with severe eosinophilic asthma who continued to have exacerbations on current medication. Read More