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FDA seeks public comment regarding four-year strategic priority document

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday made available a draft of its strategic priorities over the next four years for public comment. 
 
The agency identified four core mission goals and objectives, to include enhancing oversight of FDA-regulated products; improving and safeguarding access to FDA-regulated products in an effort to benefit health; promoting better informed decisions about the use of FDA-regulated products; and strengthening organizational excellence and accountability. 
 
Among the FDA's objectives in enhancing oversight, the agency will be seeking to strengthen detection and surveillance of problems with FDA-regulated products. "The FDA is working closely with domestic and international partners to increase information-sharing  and enhance collaborations on compliance and training efforts to expand the collective safety net," the agency wrote. The agency also is looking to expand its postmarket surveillance of products by using more active surveillance tools versus passive tools. "For example, the Sentinel Initiative is a proactive system that complements existing systems that FDA has in place to track reports of adverse events linked to the use of our regulated products. The system enables FDA to actively query diverse automated healthcare data holders — like electronic health record systems, administrative and insurance claims databases and registries — to evaluate possible medical product safety issues quickly and securely, while maintaining the privacy of patients."
 
And in an effort to improve access to FDA-regulated medicines, the agency is looking to speed up the approval process. "Although FDA has made tremendous strides in recent years in the review of new drugs, and now leads the world in both timeliness and quantity of significant new drugs approved for marketing, in the past decade, the overall development of some products crucial to public health, such as antibiotics, has slowed significantly," the agency noted. The agency acknowledged that the current costs associated with drug development may serve as a barrier to investment, especially among specialty medicines. "If biomedical science is to deliver on its promise, scientific creativity and effort must also focus on improving the medical product development process itself, with the explicit goal of robust development pathways that are efficient and predictable and result in products that are safe, effective and available to patients."
 

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FDA grants accelerated approval to Beleodaq

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced approval for Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), which is a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

The drug works by stopping enzymes that contribute to T-cells becoming cancerous. It's indicated for patients whose disease has returned post-treatment or those patients who did not respond to previous treatment.

“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,900 will die. PTCL makes up about 10% to 15% of NHLs in North America, the agency said.

 

Beleodaq is marketed by Spectrum Pharmaceuticals.

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Novartis shipping 30 million doses of influenza vaccine well ahead of 2014-2015 season

BY Michael Johnsen

CAMBRIDGE, Mass. — Novartis on Wednesday announced that it has begun shipment of its seasonal influenza vaccines to customers in the U.S. market for the 2014-2015 season. Novartis plans to ship a minimum of 30 million doses of vaccines (Flucelvax and Fluvirin). 
 
Flucelvax, which is approved for use in adults 18 years of age and older, is manufactured with cell-culture technology, a modern, alternative production method for influenza vaccines to the traditional egg-based production method. 
 
Fluvirin is indicated for persons 4 years and older.
 
Novartis is the only influenza vaccine manufacturer to use production technologies based on cell-culture (Flucelvax) as well as eggs (Fluvirin), the company stated.
 

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