FDA reviews Amgen’s prostate cancer drug Xgeva
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Comments (0)EpiCept seeks FDA Fast Track designation for AmiKet to treat CIPN
EpiCept Corporation today announced that it has filed for Fast Track designation for AmiKet(amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration.
Orexigen reaches SPA agreement for Contrave outcomes trial with FDA
Orexigen Therapeutics, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for the Contrave outcomes trial.
MindChild seeks FDA pre-market clearance for MERIDIAN non-invasive fetal heart monitor
MindChild Medical, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its MERIDIAN non-invasive fetal heart monitor.
AHF calls for top to bottom shake-up of management at FDA
AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of ...
FDA grants Mylan tentative approval for Atorvastatin Calcium ANDA
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg.
Medical Device Industry And FDA Reach Provisional Fees Agreement
An agreement, in principle, regarding proposed recommendations for the new reauthorization of a medical device user fee program, has been agreed by the FDA and the Medical Device Industry. If the recommendations go through, the FDA would be authorized to collect $595 million from the medical device industry in user ...
Carbendazim In Orange Juice – FDA Informs Juice Products Association
The following is an addendum to a FDA Letter to the Juice Products Association dated January 9, 2012. This information will be updated, as appropriate, on Friday of every week. January 27, 2012 The FDA is currently testing samples of orange juice shipments from all countries and manufacturers that ...
Medical device industry, FDA reach agreement in principle on user fee program
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.
FDA approves new skin cancer drug
A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable accomplishment in new drug development.
FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen
SCOTTSDALE, Ariz. Feb 1, 2012 A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable accomplishment in new drug ...
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Cystic fibrosis drug gets FDA approval
A drug – the first of its kind - that treats the root cause of cystic fibrosis won approval Tuesday. This could be a ray of hope for patients with the deadly illness and broader hope for thousands more patients with the inherited disease.