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  • Article

    FDA Announced That The Following Collections Have Been Submitted To OMB - April 2015

    Evaluation of the Food and Drug Administration's "Fresh Empire" Multicultural Youth Tobacco Prevention Campaign.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announced The Opportunity To Comment On The Following Proposed Information Collections - April 2015

    Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
Jones Day
  • Article

    FDA Announces 2017 Fee Rates For Domestic And Foreign Facility Reinspection, Recall, And Importer Reinspection

    FDA announced the fiscal year 2017 fee rates for certain domestic and foreign facility reinspections.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Approval Of Praluent (Alirocumab) Through PRV Program

    In the August 24, 2015, Federal Register, FDA announced the approval of Praluent (alirocumab), under an application for which the sponsor redeemed a rare pediatric disease PRV.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Availability of Environmental Assessment Supporting Food Additive Petition for Use of Ethoxyquin in Vitamin D Formulations

    Notice of the food additive petition was published on December 23, 2013.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Availability Of Grant Funds To Develop Branded Foods Products Database For Public Health

    In the February 24, 2015, Federal Register, FDA announced the availability of grant funds for the support of the Agricultural Technology Innovation Partnership's ("ATIP") Branded Food Products Database for Public Health.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Filing Of Food Additive Petition For Use Of Humic Substances As Source Of Iron In Animal Food

    In the January 6, 2015, Federal Register, FDA announced the filing of a citizen petition that the food additive regulations be amended to provide for the safe use of humate, fulvic acid, and humic substances...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Grants To Increase Food Safety Collaboration

    In the May 28, 2015, Federal Register, FDA announced the availability of grant funds to support the National Center for Food Protection and Defense ("NCFPD").
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Grants To Teach School-Aged Children About Food Safety And Nutrition

    In the June 2, 2015, Federal Register, FDA announced the availability of grant funds for the support of the Center for Food Safety and Applied Nutrition's Education and Outreach Program Targeting School-Aged Children.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Intent To Review Study Data Reviewer's Guide Template

    In the July 23, 2015, Federal Register, FDA and the Center for Drug Evaluation and Research announced the establishment of a public docket to collect comments related to a proposed Study Data Reviewer's Guide template.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces New Director For CFSAN

    She will take over the CFSAN position from Landa, who has led the Center since 2010.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces New Program For Electronically Submitting Vaccine Adverse Events

    In the April 29, 2016, Federal Register, FDA announced the availability of a Vaccine Adverse Event Reporting System, or VAERS, eSubmitter program for the electronic submission of postmarketing individual case safety reports...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Participation In International Medical Device Regulators Forum

    In the August 19, 2015, Federal Register, FDA announced that CDRH and related offices are participating in the International Medical Device Regulators Forum's ("IMDRF") Regulated Product Submission Table of Contents Pilot Program. IMDRF developed a comprehensive Table of Contents for Non-In Vitro Diagnostics and for In Vitro Diagnostics marketing authorizations.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Pilot Project For Risk Evaluation And Mitigation Strategies

    In the October 6, 2015, Federal Register, FDA announced the beginning of a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Pilot Project To Evaluate Systems For Receiving Postmarketing Vaccine Safety Reports

    The Center for Biologics Evaluation and Research announced a pilot project to evaluate its systems for receiving postmarketing safety reports involving vaccines.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Plan To Improve Premarket Review Of Medical Device Submissions

    By way of Federal Register notice, the Food and Drug Administration (FDA) just made available data from the independent assessment of medical device submissions.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Fox Rothschild LLP
    Fox Rothschild LLP
  • Article

    FDA Announces Public Workshop On Antibacterial Drug Development

    In the May 31, 2016, Federal Register, FDA announced an upcoming public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Quality Metrics Draft Guidance And Public Meeting

    FDA recently released a draft guidance document titled, Request for Quality Metrics, designed to explain how the CDER and the CBER collect and use quality metrics...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Read The Label Youth Outreach Campaign

    On June 3, FDA announced its outreach campaign to teach young people (ages 9–13) to use the Nutrition Facts Label to make healthy food choices.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Reinspection And VQIP Fees For Fiscal Year 2020

    The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Showing 541–560 of 14474 results

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