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Advertising & Promotion

  • Nov 8, 2017
    State Appeals Court Finds Insurers Do Not Have To Defend Drug Companies in Opioid Lawsuits
  • Nov 8, 2017
    NAD Refers Synergy Drug Claims to FTC; Company Contends FDA Has Jurisdiction
  • Nov 6, 2017
    Senator Questions Alkermes Marketing of Opioid Addiction Treatment
  • Nov 3, 2017
    Alaska Sues Purdue over Opioid Marketing
  • Nov 2, 2017
    Missouri Expands Opioid Investigation
  • Nov 2, 2017
    New Jersey Sues Purdue over Opioid Marketing
  • Nov 1, 2017
    N.J. Formally Proposes Regulation Capping Physician Payments and Limiting Meal Costs
  • Oct 28, 2017
    Chamber Institute Wants FDA, FTC To Regulate Medical Product Lawsuit Ads
  • Oct 27, 2017
    Seven Insys Executives Charged with RICO, Fraud and Anti-Kickback Conspiracies
  • Oct 26, 2017
    District Court Approves Order Against Company, Individuals Promoting Weight-loss Products
  • More

Good Clinical Practice

  • Mar 20, 2018
    SACHRP Recommends Five FAQs on Broad Consent
  • Mar 20, 2018
    FDA Posts First CSR Under Pilot Program
  • Mar 19, 2018
    SACHRP Recommends Three Categories of Research To Consider for Exceptions to Single IRB Review
  • Mar 6, 2018
    EMA Adopts Revised Guideline for Alzheimer’s Disease Clinical Studies
  • Mar 6, 2018
    FDA Wants Comment on ICH Topics
  • Mar 5, 2018
    Initial Result Reporting May Show Exaggerated Treatment Effect
  • Mar 2, 2018
    Addendum to ICH GCP Guidance Issued
  • Mar 1, 2018
    Draft Guidance Details Standardized Format for Electronic Submission of Data from Key Studies
  • Feb 28, 2018
    Miss. Governor Approves Bill Clarifying Research Involving Minors
  • Feb 26, 2018
    FDA Meeting Considers CIDs for Trials
  • More

U.S. Food Labeling

  • Sep 30,2012
    Suit Targeting Benecol Dismissed on Preemption
  • Sep 30,2012
    Poll Numbers Point to Victory for Ballot Measure Requiring Labeling of GMO Foods in California
  • Sep 30,2012
    Top Contributors in the Fight over Proposition 37
  • Sep 30,2012
    U.S.-Based Coalition Sues WTO over COOL Ruling
  • Sep 30,2012
    Diet Plan Marketer Agrees To Pay $3.7 Million To Settle FTC Charges of Violating 1992 Deal
  • Sep 30,2012
    Product Recalls
  • Aug 31,2012
    Texas Fajita Maker Settles with U.S. Attorney's Office and FSIS over Mislabeling Charges
  • Aug 31,2012
    N.J. Lemon Juice Maker Gets FDA Warning Letter
  • Aug 31,2012
    FSIS Will Issue Updated Guidance for Labeling of Meat and Poultry Raised without Antibiotics
  • Aug 31,2012
    CSPI Takes General Mills and McNeil Nutritionals to Court over Labeling Claims; Welch Foods Warned
  • More

FDA Regulation & Enforcement

  • Nov 24, 2020
    OPDP Adds Five-day Screening Period to Core Launch Review
  • Nov 18, 2020
    Federal Bankruptcy Court Approves DOJ's $8 Billion Global Settlement with Purdue Pharma
  • Nov 17, 2020
    HHS OIG Issues Special Fraud Alert on Speaker Programs
  • Nov 12, 2020
    FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen
  • Nov 11, 2020
    Ninth Circuit Refuses To Block Civil Enforcement Action by Hawaii Against Plavix Manufacturers
  • Nov 11, 2020
    Kentucky Supreme Court Reverses Preemption-Based Ruling Against Plaintiffs Involving Catheter with IDE
  • Nov 8, 2020
    Medtronic Agrees To Pay $9.2 Million To Settle FCA Case
  • Nov 5, 2020
    DOJ Seeks Injunction Against Animal Drug Maker After Four Years of Alleged cGMP Violations
  • Oct 31, 2020
    District Court Dismisses FCA Case Over Alleged Off-Label Marketing of Cancer Drug
  • Oct 29, 2020
    Former President of Ice Cream Manufacturer Indicted on Charges Related to 2015 Listeria Outbreak
  • More

Medical Devices

  • Jul 2, 2015
    Former CEO Sentenced to Two Years Imprisonment for Shipping Knee Cut Devices Lacking FDA Clearance
  • Jun 30, 2015
    CDRH Offers Draft Guidance To Help Make Testing for MRI-related Heating Manageable
  • Jun 25, 2015
    Draft Guidance Outlines Recommendations for Direct Marking with Unique Device Identifiers
  • Jun 25, 2015
    Second Circuit Affirms Dismissal of Products Liability Claims Against Device Manufacturer
  • Jun 19, 2015
    FDA Clarifies Risk-Benefit Factors for Device Studies
  • Jun 16, 2015
    OMB Approval Clears Way for FDA To Survey Health Care Providers About Standardized Device Labeling
  • Jun 9, 2015
    Timelines Set for Development of Two Guidance Documents Under IMDRF Single Audit Program
  • Jun 4, 2015
    House Ways and Means Committee Advances Bill To Repeal Medical Device Excise Tax
  • May 28, 2015
    FDA Issues Safety Communication on Dermal Fillers, Asks Manufacturers To Consider Labeling Changes
  • May 19, 2015
    FDA Offers Decision Tree for Leveraging Adult Clinical Device Data for Pediatric Indications
  • More

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