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Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a California federal district court. Read More
The FDA and the European Medicines Agency released a draft joint plan Monday to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Read More
Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Read More
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More
Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Read More
The owner and compliance director of Pharmakon Pharmaceuticals routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More
The FDA is improving its response times for generic drug applications, but facility inspections remain a major hang-up in the process, according to a GAO report. Read More
The FDA broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. The drugmaker’s continued GMP violations already kept most of the company’s products out of the U.S. market, but shortages led regulators to allow a handful of Ipca’s drugs into the country. Read More