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FDA

Food and Drug Administration

  • 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).

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567840.htm
    Thu, 20 Jul 2017 13:44:00 -0400
  • 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 resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567565.htm
    Wed, 19 Jul 2017 09:46:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm
    Tue, 18 Jul 2017 14:23:00 -0400
  • 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 to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567309.htm
    Mon, 17 Jul 2017 16:42:00 -0400
  • 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 over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm566958.htm
    Thu, 13 Jul 2017 13:24:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm566876.htm
    Thu, 13 Jul 2017 10:30:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm566084.htm
    Fri, 07 Jul 2017 11:16:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565874.htm
    Thu, 06 Jul 2017 10:19:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm
    Mon, 03 Jul 2017 13:17:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565463.htm
    Fri, 30 Jun 2017 14:03:00 -0400
  • 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, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565321.htm
    Thu, 29 Jun 2017 16:44:00 -0400
  • 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 FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565148.htm
    Thu, 29 Jun 2017 09:38:00 -0400
  • 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 also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564725.htm
    Tue, 27 Jun 2017 09:57:00 -0400
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564681.htm
    Mon, 26 Jun 2017 20:06:00 -0400
  • 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 self-injection by the patient or caregiver, once proper training is received.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564332.htm
    Thu, 22 Jun 2017 17:15:00 -0400
  • 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, spices, pasta, dried beans, tea and cookies.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm563869.htm
    Tue, 20 Jun 2017 13:24:00 -0400
  • 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 than 400 youth become daily cigarette smokers. It is also clear from these most recent numbers that youth are continuing to experiment with, or becoming regular users of, a wide range of other tobacco products.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm563338.htm
    Thu, 15 Jun 2017 13:49:00 -0400
  • 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, Alberto Hoyo and Juan Carlos Billoch.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm563324.htm
    Thu, 15 Jun 2017 12:33:00 -0400
  • 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 policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562961.htm
    Tue, 13 Jun 2017 09:03:00 -0400
  • 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 no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm
    Thu, 08 Jun 2017 16:15:00 -0400

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