Drugs can end up on the FDA shortage list for many reasons, with manufacturing problems and recalls often being the culprit. But a new report says that for more than a decade, poor management by the Drug Enforcement Agency and a touchy relationship between the DEA and FDA have been at the heart of many shortages of controlled substances.
The decision by Irish drugmaker Alkermes to narrow its focus and sell a manufacturing plant is providing a chance for Pennsylvania-based Recro Pharma to expand its pain drug position and jump into the the contract manufacturing space to pick up some extra cash.
Several factors in the manufacturing process can lead to a drug shortage. Now, the FDA has launched an effort to combat the effects of such shortages, bringing the battle to your smartphone.
Hospitals continue to pressure Roche's Genentech to stop using specialty distributors for some of its cancer meds. The latest move is a survey in which not only do respondents claim the change is costing them money, but more than a quarter said it is delaying patient care, The Wall Street Journal blog Pharmalot reports.
The ability of Maine consumers to get cheaper drugs from across the Canadian border has been on-again and off-again. Now it is off again.
Gilead has named Mylan as the exclusive distributor of branded forms of its hepatitis C blockbusters Sovaldi and Harvoni in India.
The Indian government has revealed details of its plan to establish itself as a supplier of low-cost, high-quality generic medicines. Instead of relying on the big beasts of Indian generics production, the government is to source its drugs from small and medium-sized players.
Federal authorities have extracted another guilty plea from a doctor found to be using unapproved foreign versions of drugs on his patients, including Rituxan, Remicade and Prolia. The Kentucky physician, who bought the drugs at a deep discount from the U.K., will pay more than half a million dollars in restitution and has received a year of probation.
A loose hair has contributed to the nationwide shortage of saline solution, as Hospira recalls another lot of the commonly used product.
SINGAPORE-- Australia's Therapeutic Goods Administration (TGA) has updated guidance on the release of medicine products from the last manufacturer in the supply chain responsible for certifying the quality before the products are released onto the Australian market.