FDA issues final rule on sterility testing of biological products
The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA approves new orphan drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
FDA permits marketing of a new device for abdominal surgery
On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery. The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one […]
FDA approves new antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.
FDA challenges marketing of DMAA products for lack of safety evidence
The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
FDA approves Stendra for erectile dysfunction
The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.
FDA Statement on USDA Announcement of Positive BSE Test Result
This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or “mad cow” disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state […]
FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease
The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).
FDA approves Votrient for advanced soft tissue sarcoma
The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.
FDA strengthens international collaboration to ensure quality, safety of imported products
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
Report: FDA strengthens monitoring of post-approval drug safety
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for […]
FDA issues draft guidance on nanotechnology
Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.
U.S. Marshals seize ultrasound gel product at a New Jersey company
U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product samples contained dangerous bacteria.