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FDA

Food and Drug Administration

  • Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

    Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610869.htm
    Fri, 15 Jun 2018 10:04:00 -0400
  • FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

    : FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm
    Thu, 14 Jun 2018 16:49:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

    Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610641.htm
    Thu, 14 Jun 2018 09:26:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

    FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610509.htm
    Tue, 12 Jun 2018 10:44:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

    The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610503.htm
    Tue, 12 Jun 2018 10:20:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

    Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610415.htm
    Tue, 12 Jun 2018 09:33:00 -0400
  • Federal judge enters consent decree against Delta Pharma

    Federal judge enters consent decree against Delta Pharma

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610339.htm
    Fri, 08 Jun 2018 16:39:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

    Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610206.htm
    Thu, 07 Jun 2018 13:41:00 -0400
  • FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

    FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610146.htm
    Wed, 06 Jun 2018 16:27:00 -0400
  • FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

    FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610081.htm
    Wed, 06 Jun 2018 10:31:00 -0400
  • FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

    FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609951.htm
    Tue, 05 Jun 2018 14:19:00 -0400
  • FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

    FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609869.htm
    Tue, 05 Jun 2018 11:27:00 -0400
  • FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

    FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609862.htm
    Tue, 05 Jun 2018 10:08:00 -0400
  • FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

    FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm
    Mon, 04 Jun 2018 16:53:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office

    FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609647.htm
    Mon, 04 Jun 2018 08:55:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

    FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609453.htm
    Thu, 31 May 2018 14:23:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

    FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609365.htm
    Thu, 31 May 2018 08:21:00 -0400
  • FDA approves first artificial iris

    FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609291.htm
    Wed, 30 May 2018 15:13:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

    FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609275.htm
    Wed, 30 May 2018 14:43:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

    FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609258.htm
    Wed, 30 May 2018 12:20:00 -0400

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