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Advertising & Promotion

  • Feb 25, 2019
    Senator Questions FDA on Opioid Marketing
  • Feb 16, 2019
    Oregon Bill Would Require Wholesale Price Disclosure in Drug Ads
  • Feb 16, 2019
    Whistleblower Takes Gilead To Court Over Its FOCUS Program
  • Feb 15, 2019
    Study Finds Industry Payments To Cancer Physicians Over Time Increase Prescribing Rates
  • Feb 14, 2019
    FDA Begins Efforts To ‘Modernize’ Dietary Supplement Oversight
  • Feb 13, 2019
    Washington Senate Bill Calls for 2 Percent Tax on Drug Advertising Revenues
  • Feb 13, 2019
    Changes Are Coming in DTC TV Advertising
  • Feb 12, 2019
    N.Y. Assembly Considers Bill Requiring Drug Makers To Report Gifts To Healthcare Practitioners
  • Feb 10, 2019
    J&J Will Add Pricing Info to DTC TV Ads
  • Feb 8, 2019
    Michigan Bill Calls for Cost Reporting
  • More

Good Clinical Practice

  • Mar 26, 2019
    Duke Pays $112.5 Million in Settlement Over Research Misconduct
  • Mar 26, 2019
    Idaho Gov. Signs Bill Mandating Insurance Payment of “Routine” Trial Costs
  • Mar 26, 2019
    R.I. Trials Website Bill Needs More Study
  • Mar 25, 2019
    OHRP Releases Guidance on Revised Common Rule
  • Mar 23, 2019
    FDA Places Partial Hold on Multiple Myeloma Trial
  • Mar 22, 2019
    Pa. House Considers Insurance Payment of Routine Patient Costs in Cancer Trials
  • Mar 21, 2019
    Health Canada Opens Trial Data Portal
  • Mar 21, 2019
    FDA Issues Warning Letters Over Companies’ Failure To Conduct Post-approval Studies
  • Mar 21, 2019
    OHRP OKs Sloan Kettering Cancer Center’s Human Research Protections Program
  • Mar 21, 2019
    U.K. Issues Guidance on Trial Registration, Results Reporting Post Brexit
  • More

U.S. Food Labeling

  • Dec 29,2015
    Mars Dove Chocolate, Zatarain’s Red Beans and Rice Lead Recall List
  • Dec 23,2015
    FDA 2016 Spending Bill Void of Preemption on State-based GMO Labeling Laws
  • Dec 17,2015
    Spate of Recent Recalls Caused by Undeclared Food Allergens
  • Dec 10,2015
    CSAF, Other Associations Push for National Food Labeling Standard for GMOs
  • Dec 3,2015
    Food Products Branded for Wegmans, Girl Scouts Recalled Due to Undeclared Allergens
  • Nov 24,2015
    NAD Asks FDA, FTC To Resolve Dispute Over Danish-labeled Cookies Made in Indonesia
  • Nov 19,2015
    FDA Proposes Using Alternative Ways To Verify Fermented or Hydrolyzed Foods Are Gluten-Free
  • Nov 19,2015
    House E&C Committee Advances Bill Revising Menu Labeling Requirements
  • Nov 12,2015
    FDA Changes Stance on ‘Natural’ Definition, Now Seeks Feedback on Defining the Term
  • Nov 5,2015
    Warning Letter Targets French Manufacturer Over Alleged Food Labeling Violations
  • More

FDA Regulation & Enforcement

  • Jul 14, 2022
    District Court: Device-Related Personal Injury Claims as Presented in Complaint Are Preempted
  • Jul 8, 2022
    FTC Consent Order Bans Two Companies and Owner from Advertising or Selling Dietary Supplements
  • Jul 7, 2022
    Minn. Court Dismisses Nexus Pharma’s Allegations That Outsourcing Facility Illegally Produced Copy of Its Drug
  • Jul 7, 2022
    National Chicken Council Wants FDA, FSIS To Address Allegedly Misleading Plant-based Product Marketing Claims
  • Jul 6, 2022
    $1 Million Settlement Resolves DOJ Suit Against Device Distributor, Physician-Owned Distributorships
  • Jul 1, 2022
    Release of FDA’s Final Rule on DTC Drug Ads Pushed to May 2023
  • Jun 30, 2022
    OIG Reports Improved Timelines, Investigator Training Gaps for Foreign For-Cause Drug Inspections
  • Jun 29, 2022
    DOJ Statement of Interest Links FD&C Act Violations to Possible Liability Under the False Claims Act
  • Jun 27, 2022
    Oregon Issues Permanent Rules for Drug Sales Rep Licensing
  • Jun 23, 2022
    Florida Man Charged in Two Cases With Widespread Distribution of Adulterated Medications
  • More

Medical Devices

  • Sep 25, 2018
    FDA Finalizes Guidance on Benefit, Risk Factors in Substantial Equivalence Reviews of New Technology
  • Sep 17, 2018
    Private Payor Program Expands To Help Device Makers Speed Insurance Coverage Determinations
  • Sep 11, 2018
    Sponsors of Some Devices May Submit 510(k)s to FDA Electronically Under New CDRH Pilot Program
  • Sep 3, 2018
    Draft Guidance from CDRH, CBER Explains Review Process for Denials of Device Export Certificates
  • Aug 28, 2018
    FDA Proposes List of Distinct Medical Device Accessories Suitable for Class I Under FDARA
  • Aug 23, 2018
    Companies Battle Before NAD Over ‘Dry Mouth’ and ‘Saliva Substitute’ Products
  • Aug 23, 2018
    Court Dismisses False Claims Allegations that Device Manufacturer Overcharged Government for Shipping
  • Aug 22, 2018
    District Court Allows Lawsuit Questioning Whether a 510(k) Device Can Be Advertised as FDA-Approved
  • Aug 21, 2018
    Voluntary Summary Quarterly MDR Program for Manufacturers Goes into Effect; FDA Notice Sets Scope, Conditions
  • Aug 15, 2018
    GUDID Data Submission Compliance Date Extended by One Year for Device Constituents of Some Combination Products
  • More

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