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  • Article

    FDA Announces Renewal Of Nonprescription Drugs Advisory Committee

    In the September 3, 2015, Federal Register, FDA announced the renewal of the Nonprescription Drugs Advisory Committee by the FDA Commissioner.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Revisions To CGMP, Hazard Analysis Proposed Rule

    FDA proposed to add CGMP requirements and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for food.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
Jones Day
  • Article

    FDA Announces The Filing Of Color Additive Petition For Egg Decorating Kits

    In the February 5, 2015, Federal Register, FDA announced that a petition has been filed proposing that the color additive regulations be amended...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announces Withdrawal Of Food Additive Petitions For Infant Formula

    FDA announced the withdrawal of a food additive petition proposing the food additive regulations be amended to prohibit the use of carrageenan in infant formula.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Approves Food Additive

    This action is in response to a food additive petition filed by Alzchem AG.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Approves Food Additive - 16 February 2017

    This action is in response to a food additive petition filed by BASF Corp.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Approves New Sugar Substitute Advantame

    The water-soluble white powder is the sixth artificial sweetener to obtain approval from FDA.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Authorizes Two New EUAs For Ebola Detection

    In the December 24, 2014, Federal Register, FDA announced two Emergency Use Authorizations for in vitro diagnostic devices that detect the Ebola Zaire virus.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Classifies Gastrointestinal Multiplex Assay Into Class II

    In the November 2, 2015, Federal Register, FDA issued a final order classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Classifies Nucleic Acid-Based Devices For Detection Of Antibiotic Resistant TB

    FDA Classifies Nucleic Acid-Based Devices For Detection Of Antibiotic Resistant TB
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Classifies Oral Electronic Vision Aid

    In the September 22, 2015, Federal Register, FDA announced the classification of the oral electronic vision aid into class II (special controls).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Confirms Effective Date For Final Rule On Confidentiality Of NADA File Data

    FDA confirmed the July 30 effective date of the final rule which amended the regulation regarding the confidentiality of data about new animal drug application files.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Confirms Increase In Civil Monetary Penalties Effective June 18

    In the June 6 Federal Register, FDA confirmed the direct final rule revising the regulations on civil penalties will be effective on June 18.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Confirms Maximum Civil Penalties Effective June 18

    The rule increased the maximum CMP amount anywhere from $1,000 to $25,000 per individual, $10,000 to $25,000 per violation.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Deletes Four System Of Records Notices

    In the June 27 Federal Register, FDA announced it will delete four system of records notices from its existing inventory of SORNs.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Determines Certain Drugs Not Withdrawn For Safety Or Effectiveness

    In the May 29 Federal Register, FDA determined that certain SODIUM PERTECHNETATE products were not withdrawn for reasons of safety or effectiveness.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Determines Regulatory Review Period For JUXTAPID Patent

    In the April 6, 2015, Federal Register, FDA published its determination regarding the regulatory review period for the drug JUXTAPID.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Determines Regulatory Review Periods For Drug And Biologic Patents

    In recent issues of the Federal Register, FDA published determinations regarding the regulatory review periods for patent extensions of BRILINTA and YERVOY.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Determines SODIUM SULAMYD Drug Products Were Not Withdrawn For Reasons Of Safety Or Effectiveness

    This determination allows FDA to approve any future or pending abbreviated new drug applications for this product, if all other legal and regulatory requirements are met.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Determines That Certain Drugs Not Withdrawn From Sale For Safety Or Effectiveness

    FDA determined that the following drugs were not withdrawn from sale for reasons of safety or effectiveness...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Showing 141–160 of 14474 results

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