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Advertising & Promotion

  • Nov 14, 2019
    TGA Warns About Using ‘Stem Cells’ in Ads
  • Nov 12, 2019
    French Physicians Not Receiving Company Gifts Prescribe Lower Cost Drugs
  • Nov 12, 2019
    DOJ, OIG Detail Enforcement Plans
  • Nov 8, 2019
    FTC Releases Influencer Disclosure Guidance
  • Nov 6, 2019
    OPDP Researchers To Examine Understanding of Terms and Phrases Used in Drug Promotion
  • Nov 4, 2019
    Point of Care Media Provide Verification And Validation Requirements
  • Nov 4, 2019
    Former Sales Rep Pedals Compounded Drugs Illegally
  • Nov 4, 2019
    Virginia Sues Teva Over Fentanyl Marketing
  • Nov 4, 2019
    Dr. Stephen Hahn Named as Next FDA Commissioner; Sharpless Returns to National Cancer Institute
  • Nov 1, 2019
    Media Company To Pay $70 Million for Selling Non-existent Ads
  • More

Good Clinical Practice

  • Nov 12, 2019
    Review Finds Many Researchers Do Not Disclose Industry Payments in Journal Articles
  • Nov 12, 2019
    Florida Bill Promotes Travel Cost Reimbursement for Cancer Trial Subjects
  • Nov 8, 2019
    Group Contends EU Gene Therapy Trial Approvals Need Streamlining
  • Nov 8, 2019
    NIH Draft Data Sharing Policy Reiterates Agency Commitment To Sharing Research Results
  • Nov 4, 2019
    Dr. Stephen Hahn Named as Next FDA Commissioner; Sharpless Returns to National Cancer Institute
  • Nov 4, 2019
    UK Trial Result Reporting Improving
  • Nov 4, 2019
    CROs Pushing eClinical Applications
  • Nov 4, 2019
    Researchers Examine Recruitment and Retention in NIH’s All of Us Project
  • Nov 4, 2019
    FDA Reiterates Enforcement Authority for Postmarketing Study Requirements
  • Nov 2, 2019
    FDA Guidance Discusses Trial Designs for HDV Studies
  • More

U.S. Food Labeling

  • Dec 19,2017
    AMS Proposes To Withdraw Organic Livestock-Poultry Rule
  • Dec 12,2017
    Petition Is Filed Seeking FDA Review of Supplement
  • Dec 12,2017
    More Time Given to Comment on FDA Burden Reduction
  • Dec 7,2017
    FTC, Supplements: Charges Are Settled in Two Cases; Suit in N.Y. Is Dismissed
  • Nov 21,2017
    FDA, USDA Recalls Decline
  • Nov 21,2017
    What Foods Are ‘Organic’?
  • Nov 21,2017
    In Warning Letters, FDA Claims Labels Are Misleading
  • Nov 16,2017
    Effective Date of Organic Livestock, Poultry Rule Is Further Postponed
  • Nov 16,2017
    Senators Warn USDA About Using QR Codes
  • Nov 8,2017
    FDA’s Menu Labeling Guidance Provides ‘Practical’ Help to Industry
  • More

FDA Regulation & Enforcement

  • Aug 7, 2023
    New Zealand Tightens Direct-to-Consumer Advertising Law
  • Aug 3, 2023
    California Dairy Enters Into Consent Decree To Resolve Allegations That It Marketed Raw Milk Products
  • Jul 31, 2023
    Supplement Company Settles Allegations of False Advertising
  • Jul 26, 2023
    Former Regulatory Affairs Employee Pleads Guilty to Faking FDA 510(k) Clearances for Two Devices
  • Jul 26, 2023
    Third Circuit Says Undisclosed API Source Does Not Make Drug ‘Unapproved,’ Nixes Conspiracy Charge
  • Jul 21, 2023
    Illinois To Push Voluntary Uniform Food Product Dating Terms
  • Jul 20, 2023
    Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices
  • Jul 19, 2023
    Teva Denied Summary Judgment in Kickback, False Claims Case Over Funding of Medicare Drug Co-Pays
  • Jul 19, 2023
    District Court: Failure-To-Warn Claim Survives Federal Preemption in Filshie Clip Litigation
  • Jul 12, 2023
    Diagnostics Firm Penalized by SEC for Allegedly Misleading Press Releases About a COVID-19 Test
  • More

Medical Devices

  • Oct 1, 2020
    Three Final Guidance Documents for Pilot on Assessing Conformity with Consensus Standards Released
  • Sep 23, 2020
    Proposed Rule Outlines Evidence Relevant to FDA’s Determination of Intended Uses of Medical Devices
  • Sep 16, 2020
    Guidance Explains How FDA Recognizes, Withdraws Voluntary Consensus Standards for Medical Devices
  • Sep 9, 2020
    Draft Guidance Offers Recommendations for Capturing Patient Perspectives When Developing, Evaluating Devices
  • Sep 2, 2020
    HHS Blocks FDA From Requiring Premarket Review of Laboratory-Developed Tests Without Rulemaking
  • Aug 16, 2020
    FDA Details Requirements for Device Listing and Facility Registration During COVID-19 Emergency
  • Aug 15, 2020
    Ninth Circuit Rejects Preemption Defense, Finding Special Controls Were Not Specific to the Device
  • Aug 12, 2020
    FDA Offers Guidance on Importing Medical Devices During the COVID-19 Public Health Emergency
  • Aug 5, 2020
    FDA Launches Pilot Program for Electronic Submission of Combination Product Requests for Designation
  • Aug 3, 2020
    FDA Authorizes First Tests for Estimating Antibodies From COVID-19 Infections, Posts OTC Test Template
  • More

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