Elizabeth Pharmacy is seeking a pharmacy technician. If you are interested contact us at 908-994-1525.

FDA

Food and Drug Administration

  • FDA approves new treatment for a rare genetic disorder, Fabry disease

    FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616598.htm
    Fri, 10 Aug 2018 16:37:00 -0400
  • FDA approves new vaginal ring for one year of birth control

    FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616541.htm
    Fri, 10 Aug 2018 13:54:00 -0400
  • FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

    FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616518.htm
    Fri, 10 Aug 2018 12:51:00 -0400
  • FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

    The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616511.htm
    Fri, 10 Aug 2018 12:02:00 -0400
  • FDA approves treatment for two rare types of non-Hodgkin lymphoma

    FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm
    Wed, 08 Aug 2018 11:33:00 -0400
  • FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

    FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616167.htm
    Wed, 08 Aug 2018 11:18:00 -0400
  • FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

    FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616137.htm
    Wed, 08 Aug 2018 13:33:00 -0400
  • FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

    FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615892.htm
    Mon, 06 Aug 2018 09:18:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

    FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615740.htm
    Fri, 03 Aug 2018 09:54:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

    Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615411.htm
    Wed, 01 Aug 2018 08:59:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

    Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615245.htm
    Tue, 31 Jul 2018 10:43:00 -0400
  • FDA approves first treatment for rare adrenal tumors

    FDA approves first treatment for rare adrenal tumors

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615155.htm
    Mon, 30 Jul 2018 15:57:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

    FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm
    Mon, 30 Jul 2018 13:41:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

    Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614851.htm
    Thu, 26 Jul 2018 09:11:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

    The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614594.htm
    Tue, 24 Jul 2018 16:42:00 -0400
  • FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

    FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614550.htm
    Tue, 24 Jul 2018 14:42:00 -0400
  • FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

    FDA continues making progress on bulk drug substances for compounding

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614281.htm
    Mon, 23 Jul 2018 12:03:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed

    The FDA responds to Bayer’s announcement to halt Essure sales in the US

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm
    Fri, 20 Jul 2018 12:59:00 -0400
  • FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

    FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614115.htm
    Fri, 20 Jul 2018 11:54:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

    FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614110.htm
    Fri, 20 Jul 2018 11:23:00 -0400

The views and opinions expressed in this feed are those of the authors and do not necessarily reflect the official policy or position of Elizabeth Pharmacy. Elizabeth Pharmacy does not warrant the accuracy, timeliness or completeness of the information contained on this feed. If you have a particular complaint about something you’ve found on this web site, feel free to contact us.