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Advertising & Promotion

  • Feb 3, 2020
    California Court Requires J&J To Pay $344 Million Over ‘False and Deceptive’ Marketing of Pelvic Mesh Products
  • Jan 29, 2020
    OPDP Announces Research Projects on Product Endorsements and Proprietary Names
  • Jan 28, 2020
    District Court in Boston Hands Down Sentences — Including Prison Time — to Seven Insys Executives
  • Jan 19, 2020
    Endo Settles with Oklahoma Over Opioid Marketing
  • Jan 15, 2020
    Former Insys Executive Sentenced to 33 Months in Prison for Role in Prior Authorization Scheme
  • Jan 8, 2020
    Teva Agrees To Pay $54 Million To Settle Qui Tam Case Involving Speaker Program Allegations
  • Jan 7, 2020
    Marketers Need New Mindsets, Skillsets and Toolkits
  • Jan 4, 2020
    Washington State Sues J&J Over Janssen Opioid Marketing
  • Dec 31, 2019
    NAD Refers Device Ad Claims to FDA, FTC
  • Dec 26, 2019
    Former Aegerion Sales Rep Convicted for Wire Fraud, Identity Theft Used in Insurance Fraud Scheme
  • More

Good Clinical Practice

  • Jan 8, 2020
    FDA Extends Comment Period for Draft Certificates of Confidentiality Guidance
  • Jan 8, 2020
    Investigator Agrees to Two-Year Voluntary Exclusion from Federal Research
  • Jan 6, 2020
    UK Cancer Group Issues Recommendations on CID Trials
  • Jan 6, 2020
    Bills Introduced in Congress to Allow Conditional Approval of Drugs After Phase 2 Trials
  • Dec 24, 2019
    NIAID Establishes Infectious Diseases Clinical Research Consortium
  • Dec 23, 2019
    FDA Issues Draft Guidance Expanding Flexibility in Demonstrating Substantial Evidence of Effectiveness
  • Dec 23, 2019
    Illinois Approves Programs To Provide Ancillary Cost Reimbursement for Cancer Trials
  • Dec 17, 2019
    Analysis of Financial CoIs Reported to NIH Since 2012 Finds Nearly Half Do Not Have Dollar Amount
  • Dec 16, 2019
    Analysis Finds More than Half of Rare Disease Trials Are Either Discontinued or Unpublished
  • Dec 14, 2019
    FDA Issues Draft Guidance To Help With Pediatric Evaluation of New Molecularly Targeted Oncology Drugs
  • More

U.S. Food Labeling

  • Jun 13,2018
    Bill Calls for Labeling Based on Science
  • Jun 6,2018
    Webinar Provides Stakeholders Overview of BE Proposal
  • May 30,2018
    Court Rules Bottled Water Mislabeling Complaint Is Preempted by FD&C Act
  • May 24,2018
    Recent Court Decisions Dismiss Suits Questioning Labeling of ‘Diet’ Sodas
  • May 12,2018
    USDA Releases Proposed GMO Labeling Rule
  • May 9,2018
    FDA Provides Additional Guidance as Menu Labeling ‘Goes Live’
  • May 2,2018
    AMS Proposes Addition, Reclassification of Items on Organic Substances List
  • Apr 26,2018
    Olive Oil Settlement Is Part of Trend in Class Action Litigation
  • Apr 18,2018
    News in Brief
  • Apr 11,2018
    Creamery Says Skim Milk Labeling Regs Violate First Amendment
  • More

FDA Regulation & Enforcement

  • Oct 25, 2023
    FDA Outlines How It Conducts Remote Interactive Evaluations of Drug and Bioresearch Facilities
  • Oct 23, 2023
    FDA Moving Ahead With FOPL Priority
  • Oct 21, 2023
    Bill Requiring Price Disclosure in DTC Ads Introduced in House
  • Oct 18, 2023
    OPDP Researchers To Examine Adherence and Preference Claims
  • Oct 16, 2023
    Former CEO Pleads Guilty to Marketing Migraine Treatment Device Without FDA’s Authorization
  • Oct 11, 2023
    Florida Man Pleads Guilty to Conspiring To Divert HIV Meds, Other Drugs Worth Up to $25 Million
  • Oct 11, 2023
    FDA ‘Unsatisfied’ With Recall of Philips Respironics Devices; Senator Calls for Enforcement Action
  • Oct 10, 2023
    Can a Brand Name Deceive Consumers?
  • Oct 4, 2023
    Genomic Test Provider To Pay $32.5 Million To Resolve Allegations of Improperly Billing Medicare
  • Oct 4, 2023
    Petitions Over Compliance Guidance and Notice of Penalty Offenses Filed With FTC
  • More

Medical Devices

  • Mar 24, 2021
    Court Declines To Dismiss on Preemption Grounds State Law Claims Involving a PMA Cardiac Device
  • Mar 17, 2021
    CDRH Reports 90 Examples of the Use of Real-World Evidence in Its Regulatory Decisions for Devices
  • Mar 10, 2021
    FDA Cautions Against Misuse of Thermal Imaging Devices, Often Used as COVID-19 Screening Tools
  • Mar 4, 2021
    Court: Plaintiffs Failed To Establish State Law Duty of Valve Makers To Report Adverse Events to FDA
  • Feb 24, 2021
    FDA Offers Recommendations for Evaluating Impact of Emerging Virus Variants on COVID-19 Tests
  • Feb 18, 2021
    Despite COVID-19, CDRH Authorized a Record Number of Novel Devices for Marketing During 2020
  • Feb 11, 2021
    Senators: FDA Should Investigate Inaccuracies in Oximeter Blood Oxygen Readings Among Persons of Color
  • Feb 3, 2021
    Massachusetts High Court Sets Broad Standard Against Preemption But Finds Claims Not To Be Plausible
  • Jan 27, 2021
    CDRH Reports Progress, Next Steps for Pilot Program Advancing Use of Consensus Standards in Submissions
  • Jan 22, 2021
    Woodcock Becomes Acting FDA Commissioner Following Hahn’s Resignation as Biden Administration Begins
  • More

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