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Advertising & Promotion

  • Jul 3, 2019
    Senate Finance Leaders Question Tax-exempt Groups Financial Relationships with Opioid Manufacturers
  • Jul 2, 2019
    Pa. Doctor Indicted on Kickback Charges
  • Jul 1, 2019
    OPDP Researchers Move Ahead with Disease Awareness Ad Research
  • Jul 1, 2019
    Court Finds Use of Image of Competing Product Was Not False Advertising
  • Jul 1, 2019
    Teva Reaches Agreement with Oklahoma Over Opioid Marketing
  • Jun 27, 2019
    Insys Sales Representative Who Cooperated with Prosecutors Is Sentenced to Five Years of Probation
  • Jun 22, 2019
    Third OPDP Untitled Letter of 2019 Cites Direct-to-Consumer Video
  • Jun 22, 2019
    FDA Issues Final Guidance on Electronic Submission of Promotional Materials
  • Jun 22, 2019
    OPDP Researchers Want To Study Oncology Indications in DTC TV Ads
  • Jun 15, 2019
    Drug Companies Sue To Stop Price Listing in DTC Ads
  • More

Good Clinical Practice

  • Aug 19, 2019
    MDIC Issues First Paper in Its Framework for Patient Input in Device Trials
  • Aug 17, 2019
    Study Finds Lack of Racial Diversity in Cancer Trials Leading To FDA Approval
  • Aug 15, 2019
    ClinicalTrials.gov Looks To Modernize
  • Aug 14, 2019
    Three Writing Groups Warn Researchers To Watch Out for Predatory Journals
  • Aug 12, 2019
    Review Finds Medical Writing Support Can Help Trial Reporting and Timeliness
  • Aug 12, 2019
    ASCO Issues Recommendations for Research Biopsies
  • Aug 9, 2019
    Group Creates Foundation To Increase and Support Physician-Researchers
  • Aug 9, 2019
    Data and Analytics Platform for Rare Disease Research Launched
  • Aug 6, 2019
    Survey Finds Spin in Journal Abstracts
  • Aug 6, 2019
    NIH Extends BESH Flexibility for Results Reporting and Registration for Two Years
  • More

U.S. Food Labeling

  • Apr 19,2017
    Health Canada Proposes Ban on Partially Hydrogenated Oils
  • Apr 13,2017
    Retail Associations Petition FDA To Halt Final Menu Labeling Rule
  • Apr 10,2017
    Alert Issued for Chocolate-Coated Frozen Desserts
  • Apr 10,2017
    Lawsuit Over Bumble Bee Tuna Labeling Claims Tossed
  • Apr 7,2017
    Boston Fisherman Pleads Guilty to Falsely Labeling Fish To Hide Overfishing
  • Apr 5,2017
    FDA Cites a Host of Labeling and Other Violations at North Hollywood Bakery Product Maker
  • Mar 30,2017
    Supplement Maker Warned for Making Prescription Drug Claims on Labels
  • Mar 23,2017
    AMS Extends Sunset Date for Substances Currently on National List
  • Mar 16,2017
    Abbott Labs Faces Trademark Infringement Suit over Mailed Similac Samples
  • Mar 12,2017
    Gottlieb Nominated To Head FDA as Commissioner of Food and Drugs
  • More

FDA Regulation & Enforcement

  • Mar 1, 2023
    OIG: No Sanctions for Providing Treatment Assistance to Pediatric Patients With Rare Immune Disorder
  • Mar 1, 2023
    Jury Returns Kickback, False Claims Verdict for Over $43 Million Against Ophthalmic Device Distributor
  • Feb 28, 2023
    FDA Debars Former Chief Executive and Former Medical Director Over Marketing Claims
  • Feb 22, 2023
    OraPharma To Pay $100K To Resolve False Claims Allegations Linked to Sales Reps’ Work as Hygienists
  • Feb 22, 2023
    Citing Preemption, Court Dismisses Claims That Surgical Clip Maker Failed To Report Adverse Events
  • Feb 22, 2023
    CDRH Issues Warning Letter Over Off-label Promotion
  • Feb 16, 2023
    USDA Strengthens Enforcement of Organic Rules
  • Feb 15, 2023
    Orthotics Manufacturer Settles DOJ, North Carolina Fraudulent Medicaid Coding Allegations
  • Feb 10, 2023
    Studies Reveal That Most DTC Advertising Is for Drugs with Low Added Clinical Benefit
  • Feb 7, 2023
    Cereal Maker Pleads Guilty, Agrees to $19.228 Million Penalty, Largest Ever in Food Safety Criminal Case
  • More

Medical Devices

  • Dec 19, 2019
    FDA Moves from Paper to Electronic Format for Device Premarket Submissions Beginning in January
  • Dec 12, 2019
    Dr. Stephen Hahn Confirmed as New FDA Commissioner
  • Dec 12, 2019
    Court Rejects FDA’s Attempt To Regulate Contrast Agents for X-Rays and CT Scans as Drugs, Not Devices
  • Dec 5, 2019
    As Device Tax Moratorium Is Set To Expire, Study Predicts More than 21,000 Industry Jobs Will Be Lost
  • Nov 26, 2019
    Pilot Program Could Help Streamline FDA Approvals of Changes in Ethylene Oxide Sterilization
  • Nov 21, 2019
    DOJ: South Dakota Surgeon, Physician-Owned Distributorships Created ‘Multiple’ Illegal Kickback Schemes
  • Nov 14, 2019
    More Detailed Recommendations Offered in Final Guidance on Device Export Certificate Denial Review Requests
  • Nov 13, 2019
    IMDRF Releases Guidance on Device Clinical Trials
  • Nov 7, 2019
    FDA Elaborates on Proposed Progressive Approval Pathway for Devices; Senators Continue Pushback
  • Nov 4, 2019
    Dr. Stephen Hahn Named as Next FDA Commissioner; Sharpless Returns to National Cancer Institute
  • More

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