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home : fda news now : fda news wire July 26, 2017

FDA clears first neonatal magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).... More Story with Video....


Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation
More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and... More Story with Video....


FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.... More Story with Video....


FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment... More Story with Video....


Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse
In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM ... More Story with Video....


Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests
On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.... More Story with Video....


FDA approves new treatment for sickle cell disease
The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.... More Story with Video....


Federal judge enters consent decree against Alabama compounder Medistat
U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.... More Story with Video....


FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.... More Story with Video....


Federal judge orders New York smoked fish company to stop sales due to food safety violations
A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.... More Story with Video....


FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma... More Story with Video....


FDA unveils plan to eliminate orphan designation backlog
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after F... More Story with Video....


FDA Tackles Drug Competition to Improve Patient Access
Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and als... More Story with Video....


Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs
In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.... More Story with Video....


FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease
The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home... More Story with Video....


U.S. Marshals seize adulterated food from a Minnesota warehouse
The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spic... More Story with Video....


Statement from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth Tobacco Survey results
While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products. Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and... More Story with Video....


Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs
Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Albert... More Story with Video....


Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new... More Story with Video....


FDA requests removal of Opana ER for risks related to abuse
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may n... More Story with Video....



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