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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
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, 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 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
Institutional review boards that fail to write explicit policies defining clinical trial noncompliance are putting themselves and their research sites at risk, an industry expert says. 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
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. 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