United States. Food and Drug Administration
Theresa Toigo, director of FDA's Office of Special Health Issues, reported a significant increase in the number of clinical trials submitted to the Clinicaltrials.gov database since September. However, she emphasized that the quality of these listings remains a concern. Toigo cited the International Committee of Medical Journal
United States. Food and Drug Administration
A US regulatory panel has ruled that pain drugs Celebrex and Bextra, made by Pfizer, and Vioxx, made by Merck, can remain on the market with strong warnings about increased heart and stroke risk. The decision was made by the Food and Drug Administration (FDA) advisory panel after a three-day
United States. Food and Drug Administration
As the world's largest drug manufacturers prepare for a tense week of regulatory scrutiny, the future of a widely used class of anti-inflammatory drugs, cox-2 inhibitors, hangs in the balance. The European Medicines Agency and the US Food and Drug Administration are set to deliver verdicts that could
Pharmaceutical industry
The Food and Drug Administration is poised to grant Cyberonics' implantable electrical device for epilepsy treatment tentative approval as a therapy for chronic depression, pending the company meeting several conditions. This decision has sent shares of Cyberonics soaring $11.53, or nearly 42 percent, to $39.01 in heavy
Pharmaceutical industry
The Food and Drug Administration has granted approval to Lyrica, a new medication developed by Pfizer Inc. to treat nerve pain associated with diabetes and shingles. Lyrica, which is expected to be available in the United States in 2005, is a successor to Pfizer's epilepsy drug Neurontin, which
Pharmaceutical industry
The recent surge in concerns about the side effects of new painkillers has sparked a heated debate about the balance between risk and relief in modern medicine. As people seeking relief from pain are increasingly alarmed by reports of the potential risks associated with new medications, the pharmaceutical industry, healthcare
Pharmaceutical industry
The combination of thalidomide plus dexamethasone has been shown to produce a statistically significant improvement in response rates compared to dexamethasone alone in patients with multiple myeloma. According to the final clinical results of a Phase III study presented at the American Society of Hematology 46TH Annual Meeting, 63% of
Pharmaceutical industry
A Phase II study evaluating the clinical results of a combination therapy of melphalan, prednisone, and thalidomide (MPT) in newly diagnosed multiple myeloma patients presented promising data at the American Society of Hematology 46TH Annual Meeting in 2004. The study, led by Antonio Palumbo, MD from the Italian Multiple Myeloma
Pharmaceutical industry
Congress is exploring the authority to grant the FDA the power to mandate post-approval studies of drugs, following the recent recall of Vioxx and other medications. This move aims to address concerns over the safety and efficacy of pharmaceuticals. FDA experts and industry professionals emphasize the need for rigorous post-marketing
Pharmaceutical industry
David Graham, a seasoned scientist in the Food and Drug Administration's Office of Drug Safety, has been thrust into the national spotlight after testifying before a Senate panel that the FDA is incapable of protecting the public from dangerous drugs once they come on the market. Graham'
Pharmaceutical industry
The Food and Drug Administration (FDA) faces criticism for its handling of drugs, with the flu vaccine crisis serving as a recent example. Despite its efforts to quickly approve new medicines, the agency's authority to monitor drug safety after market approval is shockingly weak. As a result, American
Pharmaceutical industry
The US Food and Drug Administration (FDA) has released a Compliance Policy Guide for implementing radio frequency identification (RFID) technology feasibility studies and pilot programs in the pharmaceutical supply chain. The agency aims to enhance the safety and security of the drug supply through this initiative. The FDA is also
