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  • Article

    DEA Acts On FDA Proposed Rescheduling Of Hydrocodone Combination Products

    The U.S. Drug Enforcement Agency issued a notice of proposed rulemaking to reschedule hydrocodone products from schedule III to schedule II of the CSA.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    DEA Sets New Quota Limits For Prescription Painkillers

    The Drug Enforcement Agency announced aggregate production quotas for Schedules I and II controlled substances and List I chemicals manufactured in 2015.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Publishes A Draft Guideline On Manufacture Of The Finished Dosage Form

    On July 9, 2015, EMA published a draft guideline on manufacture of finished dosage form.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Seeks Comments On Clinical Trial Regulation

    On January 21, 2015, EMA launched a public consultation on the application of the transparency rules for new Clinical Trial Regulation EU No 536/2014, which will apply to the new clinical trial database starting May 28, 2016.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA To Share Generics Assessments With Other National Regulatory Authorities

    EMA announced it will share assessment reports of generic medicines with collaborating regulatory agencies outside of the EU as part of the International Generic Drug Regulators Pilot ("IGDRP").
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Parliament Resolution Calls For A New EU Alcohol Strategy

    On April 29, 2015, the European Parliament adopted a Resolution calling on the Commission to present a new EU Alcohol Strategy to cope with health harm for 2016–2022.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Animal Drug Regulations For Approvals Of Ceftiofur Sodium, Gentamicin, Xylazine

    The FDA announced amendments to its animal drug regulations to reflect approval actions of new animal drug applications.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Animal Drug Regulations To Reflect Recent NADA And ANADA Approvals

    The FDA amended its animal drug regulations to reflect approval of actions for six new animal drug applications during January and February 2014.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Animal Drug Rules To Reflect Withdrawal And Approvals

    FDA issued a final rule amending its animal drug regulations to reflect approval actions and to remove a combination drug medicated feed that is no longer codified.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Food Additive Regulations

    In the May 4, 2017, Federal Register, FDA amended the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Food Additive Regulations

    In the November 22, 2016, Federal Register, FDA amended the food additive regulations to no longer provide for the use of two specific perfluoroalkyl-containing substances as oil and water repellents...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Food Additive Regulations To Expand Use Of Vitamin D2 And D3

    The final rule was issued in response to a food additive petition filed by the Dean Foods Company and WhiteWave Foods Company.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Food Labeling Regulations Related To Saturated Fat And Cholesterol

    FDA is making the amendment in response to a petition submitted by the American Heart Association.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Medical Device Classification Procedures

    In the December 24, 2014, Federal Register, FDA amended its regulations for petitioning for device reclassification to update mailing addresses for the petitions.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Amends Medical Device Regulations To Correct Minor Errors

    In the August 25, 2014, Federal Register, FDA announced the amendment of certain medical device regulations to correct minor errors in the regulations.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announced Filing Of Food Additive Petition

    In the July 16, 2015, Federal Register, FDA announced that Alzchem AG has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

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

    Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announced The Following Information Collections Have Been Submitted To OMB

    Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announced The Opportunity To Comment On The Following Proposed Information Collection

    Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    FDA Announced The Opportunity To Comment On The Following Proposed Information Collections

    Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles—21 CFR 514.1(b)(7-8) (OMB Control No. 0910-0575)—Extension.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Showing 101–120 of 14474 results

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