Medication management
The Food and Drug Administration Oct. 11 approved a new tablet for the acute treatment of migraine headache pain.
The AHA today urged the Drug Enforcement Administration to explicitly consider drug shortages when setting and adjusting aggregate production quotas, citing concern that the agency’s proposal to reduce 2020 production quotas for five opioid controlled substances would exacerbate shortages of…
The Drug Enforcement Administration this week proposed reducing aggregate production quotas for five opioid controlled substances in 2020.
The Centers for Disease Control and Prevention this week announced an anticipated shortage of Aplisol, one of two TB skin tests licensed by the Food and Drug Administration.
A federal court in Texas yesterday ordered Pharm D Solutions to stop producing or distributing compounded drugs intended to be sterile until the company complies with federal law and other requirements, the Food and Drug Administration announced.
The Food and Drug Administration Friday issued final guidance clarifying how sponsors may show that a proposed biosimilar product is interchangeable with a brand name biological product.
The Food and Drug Administration plans to revise its 2016 draft compounding guidance for hospital and health system pharmacies.
Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a Food and Drug Administration pilot program.
The U.S. District Court for the Western District of Pennsylvania has entered a consent decree prohibiting Ranier’s Rx Laboratory Inc. from manufacturing or distributing compounded drugs until they comply with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration regulations.
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.