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The FDA will hold a public hearing on improving distribution of medication guides with risky medications after a lawmaker questioned the guides’ distribution system, the agency announced.
A third party tampered with the labels on two GlaxoSmithKline (GSK) HIV infection medications, placing incorrect and counterfeit labels on the products, the company and the FDA announced.
The FDA’s Arthritis Advisory Committee voted 20-1 against recommending approval of Merck’s Arcoxia, a potential successor to Vioxx as a treatment for arthritis pain.
Amgen plans to announce results from an Aranesp small-cell lung cancer clinical trial when the firm reports first-quarter earnings April 23, the company said.
FDA Commissioner Andrew von Eschenbach told attendees at an April 12 industry conference that the agency needs to face “a new reality” and become a better bridge between new treatments and patients.
The FDA’s Arthritis Advisory Committee voted 20-1 against recommending approval of Merck’s Arcoxia, a potential successor to Vioxx as a treatment for arthritis pain.
U.S. Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach has announced the creation of a new office that will address cultural issues within the agency.
Bell-More Labs failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
During FDA inspections, manufacturers can use certain techniques to avoid Form 483s, or to respond to FDA observations, Cathy Burgess said during a recent FDAnews audioconference.
A key goal of Good Manufacturing Practice (GMP) training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems.