India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.
The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.
A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.
Industry is barreling toward its first direct marking requirement under the FDA's unique device identification (UDI) initiative. To help companies comply with the requirements, the agency released a Q&A-style guidance on the topic.
The Drug Supply Chain Security Act, passed by Congress in 2013, lays out a timetable for companies to be able to comply with the so-called track-and-trace rules that would allow the FDA to more easily locate recalled products and to protect against counterfeits.
This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.
When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.
Sens. Richard Burr (R-NC) and Al Franken (D-MN) recently introduced legislation that encourages the FDA to review medical devices in the "least burdensome" manner, as required under the FDA Modernization Act of 1997.
The FDA released an overview of its considerations and process for reviewing so-called investigational device exemptions, which give researchers permission to test developmental devices on humans.
The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.