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  • Article

    AMS Updates U.S. Standards For Fruits, Vegetables, Nuts, And Specialty Crops

    This revision brings these grade standards in line with other recently amended standards and current terminology.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    AMS Withdraws U.S. Standards For Livestock And Meat Marketing Claims

    In the January 12, 2016, Federal Register, USDA's AMS announced withdrawal of the U.S. Standards for Livestock and Meat Marketing Claims.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Analysis Of Medicare, Medicaid, And Other Health Policy Provisions In Bipartisan Budget Act

    The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    APHIS Amends Regulations Specifying Conditions For Payment Of Indemnity Claims For HPAI

    In the February 9, 2016, Federal Register, USDA's APHIS issued an interim rule amending regulations pertaining to certain diseases of livestock and poultry to specify conditions for payment of indemnity claims for HPAI.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Amends The National Poultry Improvement Plan And Auxiliary Provisions

    In the August 12, 2016, Federal Register, USDA's APHIS issued a final rule amending the NPIP, its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Extends Comment Period For Importation Of Lemons From Northwest Argentina

    The comment period extension will allow interested persons additional time to submit comments.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Proposes Consolidating Regulations Governing Bovine Tuberculosis And Brucellosis

    In addition, APHIS proposes to revise the bovine tuberculosis- and brucellosis-related import requirements for cattle and bison to make these requirements clearer and ensure that they more effectively mitigate the risk of introduction of these diseases into the United States.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Proposes Importation, Interstate Movement, And Environmental Release Of Certain Gmos

    . APHIS also proposed to revise its regulation regarding the movement of plant pests and soil, and proposed criteria regarding the movement and environmental release of biological control organisms.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Proposes Rule Allowing Importation Of Hass Avocados From Colombia

    Additionally, avocados from Colombia would be required to be accompanied by a phytosanitary certificate with an additional declaration stating that the avocados have been produced in accordance with the proposed requirements.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Reopens Comment Period For Proposed Rule On Lemons From Chile

    Accordingly, APHIS is reopening the comment period for an additional 30 days to give interested parties additional time to review the pathway-initiative risk assessment.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    APHIS Solicits Public Comment On List Of Threats To Animal Or Plant Health

    In the February 27, 2015, Federal Register, USDA's APHIS announced the solicitation of public comments regarding the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    BYOOVIZ® (Ranibizumab-Nuna) Granted Interchangeable Status

    Recently, Biogen and Samsung Bioepis's ranibizumab biosimilar (BYOOVIZ) was granted interchangeable status by the U.S. Food and Drug Administration. BYOOVIZ was deemed interchangeable...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    California's Licensing Authorities Propose Emergency Regulations for Medicinal and Adult-Use Cannabis Businesses

    On November 16, 2017, California's three cannabis licensing authorities announced proposed emergency licensing regulations for medicinal and adult-use commercial cannabis businesses.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Wilson Elser Moskowitz Edelman & Dicker LLP
    Wilson Elser Moskowitz Edelman & Dicker LLP
  • Article

    California Bill Requiring Warning Labels For Soda Fails In State's Health Committee

    A bill to add warning labels to sugar-sweetened drinks passed the California state Senate last month, but the state Assembly's Health Committee rejected it.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Cannabis Control Commission Update: Retail Licenses

    Although the Massachusetts Cannabis Control Commission has begun awarding provisional, adult-use licenses to some entities in the Commonwealth as of July 1, only one retail license has been awarded...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Foley Hoag LLP
    Foley Hoag LLP
  • Video

    Cannabis: Investing In One Of The Fastest "Growing" Segments Of The Life Sciences Industry (Video)

    Duane Morris partners Seth Goldberg and David Feldman, members of Duane Morris' Cannabis Law Practice Group, were panelists for an ACG webinar, "Cannabis: Investing in One of the Fastest "Growing"...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    CDRH Announces Progress Report On 2014–2015 Strategic Priority

    In the April 29, 2015, Federal Register, FDA's Center for Devices and Radiological Health issued a progress update on its 2014–2015 Strategic Priority titled "Strike the Right Balance Between Premarket and Postmarket Data Collection."
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    CDRH Solicits Industry Participation In 2015 Experiential Learning Program

    The program aims to provide CDRH staff with a better understanding of devices they review through discussions with industry leaders.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Celltrion Adalimumab Biosimilar Granted Interchangeability Designation

    On April 14, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration granted an interchangeable designation to YUFLYMA (adalimumab-aaty)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion Announces Commercial Availability Of ZYMFENTRA™ (Infliximab-dyyb)

    Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
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