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Advertising & Promotion

  • Jan 7, 2022
    OPDP Adds New Division
  • Dec 31, 2021
    Oregon Sets Temporary Rules for Sales Rep Licensing
  • Dec 24, 2021
    District Court Allows Qui Tam Suit Over Marketing Claims and Speaker Programs To Continue
  • Dec 17, 2021
    FDA Plans To Release Final Rule on DTC Ads in September
  • Dec 14, 2021
    House Committee Report Critiques Pharma Business, Pricing Practices
  • Dec 9, 2021
    Allergan Settles with New York over Opioid Marketing
  • Dec 1, 2021
    OIG Will Not Sanction Drug Maker’s Arrangement with Hospitals
  • Nov 22, 2021
    DOJ: Orthopedic Device Development Royalties Dispute with Surgeon Evolved into Illegal Kickback Scheme
  • Nov 19, 2021
    Oregon Sues Endo Over Opioid Marketing
  • Nov 18, 2021
    Biden Nominates Dr. Robert Califf To Head the FDA Again as Commissioner of Food and Drugs
  • More

Good Clinical Practice

  • Mar 7, 2022
    FDA BIMO Inspections Down 17% in FY 2021
  • Feb 25, 2022
    FDA Provides Guidance on Screening and Exit Interviews in Clinical Trials
  • Feb 20, 2022
    FDA Warning Letter Alleges Informed Consent, IRB Violations
  • Feb 15, 2022
    Proposed Senate HELP Committee Pandemic Bill Includes Provisions To Modernize Trials
  • Feb 15, 2022
    Senate Narrowly Confirms Califf as FDA Commissioner
  • Feb 10, 2022
    Bill To Increase Trial Diversity Introduced in US House
  • Jan 28, 2022
    Final Guidance on Patient Engagement in Device Trial Design and Conduct Little Changed from 2019 Draft Guidance
  • Jan 23, 2022
    EU, UK Look To Revise Clinical Trial Rules
  • Jan 14, 2022
    State Bills Focus on Clinical Research
  • Jan 12, 2022
    Clinical Trial Site Co-Owner Pleads Guilty to Obstructing FDA Inspection by Falsely Attesting to Data
  • More

U.S. Food Labeling

  • Dec 10,2020
    Court Refuses To Enjoin Oklahoma Plant-Based Meat Labeling Law; Plaintiffs Appeal
  • Nov 24,2020
    House Passes Bill To Add Sesame to Regulated List of Allergens
  • Nov 12,2020
    FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen
  • Oct 29,2020
    FDA Wants Feedback on Labeling ‘Nontraditional’ Sugars
  • Oct 15,2020
    FDA Asks for Input on Labeling Cell-based Seafood
  • Sep 29,2020
    ​​​​​​​AMS Announces Decision on OLPP Rule
  • Sep 29,2020
    NOSB Will Hold Online Meeting in Late October
  • Sep 23,2020
    FDA Extends Facts Panel Compliance Flexibility to Small Firms
  • Sep 17,2020
    FSIS Proposes To Expand Categories of Products Eligible for Generic Label Approval
  • Sep 3,2020
    Groups, Retailers Ask Court To Force AMS To Rework GMO Rulemaking
  • More

FDA Regulation & Enforcement

  • Nov 13, 2024
    Spa Owner Allegedly Performed Thousands of Injections Involving Smuggled, Counterfeit Drugs, Devices
  • Nov 9, 2024
    FDA Looks To Update ‘Healthy’ Claim, Propose FOP Labeling in FY 2025
  • Nov 6, 2024
    Supplier of APIs for Compound Rxs To Pay $21.75M To Settle Allegations of Setting False, Inflated AWPs
  • Nov 1, 2024
    CBO Finds Eliminating or Limiting DTC Ads Would Result in Very Small Reductions in Drug Prices
  • Oct 30, 2024
    Marketer of Face Masks Misrepresented as N95s, Two Executives Plead Guilty to Misbranding Charges
  • Oct 30, 2024
    Court: Claims Related to a Contraceptive Device Are Barred by Statute of Limitations and Preempted
  • Oct 25, 2024
    Senate HELP Committee To Examine FOP Labeling
  • Oct 23, 2024
    DOJ Obtains Guilty Plea for Online Sales of SARMs That Continued Despite FDA Warning Letter
  • Oct 21, 2024
    JAMA Article Reports Half of Top Journals’ Peer Reviewers Received Industry Payments
  • Oct 16, 2024
    Ninth Circuit Says FDA Can Regulate Stem Cell Clinic Procedure, Reversing Lower Court’s Holding
  • More

Medical Devices

  • Apr 12, 2023
    Trade Groups Critique EPA Proposed Rule on Use of Ethylene Oxide in Device Sterilization Facilities
  • Apr 6, 2023
    Three Executives Face Criminal Charges for Alleged Blood Lead Level Test Malfunction Cover-Up
  • Apr 5, 2023
    FDA: Draft Guidance Will Spur Development of AI/Machine-Learning Devices, Reduce Sponsor Burden
  • Mar 29, 2023
    For Transition From COVID-19 EUAs, Enforcement Policies, FDA Urges Sponsors To Prep New Submissions
  • Mar 23, 2023
    COVID-19-Related EUAs To Remain In Effect Following Expiration of Public Health Emergency
  • Mar 16, 2023
    Manufacturer To Pay $10 Million, CEO Indicted in Connection With Marketing of ‘Dummy’ Device
  • Mar 8, 2023
    Device Cybersecurity Mandates Enacted by Congress Set Premarket Submission, Monitoring Requirements
  • Mar 1, 2023
    Jury Returns Kickback, False Claims Verdict for Over $43 Million Against Ophthalmic Device Distributor
  • 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
  • More

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