FDA Statement on Senate Confirmation of Dr. Robert Califf
Category Archives: Drug Safety Information Podcasts
FDA approves Briviact to treat partial onset seizures
The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.
FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States
As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.
FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States
As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.
Maine smoked fish company agrees to halt production of adulterated fish
On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former president and owner, Ira J. Frantzman. The decree results from a complaint filed by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration.
Maine smoked fish company agrees to halt production of adulterated fish
On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former president and owner, Ira J. Frantzman. The decree results from a complaint filed by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration.
FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality
The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the Vice President.
Califf, FDA top officials call for sweeping review of agency opioids policies
In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4
The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
FDA approves first drug to show survival benefit in liposarcoma
The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.