Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
Archive for the ‘Drug Safety Information Podcasts’ category
Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
FDA Statement on Senate Confirmation of Dr. Robert M. Califf
FDA Statement on Senate Confirmation of Dr. Robert Califf
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 […]
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 […]
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 […]
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 […]
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.
FDA resolves criminal and civil actions against cheese manufacturer
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.
FDA resolves criminal and civil actions against cheese manufacturer
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.
FDA outlines cybersecurity recommendations for medical device manufacturers
The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered […]
FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk
The U.S. Food and Drug Administration today cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.
Federal judge enters consent decree against Downing Labs
On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.
FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and […]
US Marshals seize dietary supplements containing kratom
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.