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Advertising & Promotion

  • Mar 18, 2019
    Maine Bill Considers Drug Cost Reporting
  • Mar 14, 2019
    Health Canada Proposes More Restrictions on Marketing Class B Opioids to HPCs
  • Mar 13, 2019
    USDA, FDA Provide Details on Sharing Oversight of Cell Cultured Food
  • Mar 12, 2019
    Oregon Settles With Pfizer Over Coupons
  • Mar 12, 2019
    NCI Director Sharpless To Serve as Acting FDA Commissioner Following Gottlieb’s Departure
  • Mar 12, 2019
    Pa. House Considers Bill Mandating Drug Cost Reporting
  • Mar 11, 2019
    OPDP Moves Forward with HCP Survey
  • Mar 6, 2019
    FDA Issues Warning Letter for Marketing Laser as Sole Screening Device for Breast Cancer
  • Mar 5, 2019
    Gottlieb Resigns as FDA Commissioner
  • Mar 5, 2019
    Survey Finds Few Patients Looking Up Doctors on Open Payment Database
  • More

Good Clinical Practice

  • Apr 25, 2019
    CONSORT Adds Guidance for Multi-arm, Parallel-group Randomized Trials
  • Apr 23, 2019
    EC Answers Questions on Trial Data Protection
  • Apr 18, 2019
    N.C. House Approves Bill Expanding Right-to-Try To Investigational Adult Stem Cell Treatments
  • Apr 18, 2019
    CDER Statisticians Developing Adaptive Trials
  • Apr 18, 2019
    FDA Creates ‘Advisory List’ for Dietary Supplements
  • Apr 16, 2019
    FDA To Host Workshop on Analysis Standards
  • Apr 16, 2019
    Health Canada Implements ICH Guidance on Multiregional Clinical Trials
  • Apr 12, 2019
    SCRS Provides Justification for Its CLEAR Contract Language
  • Apr 12, 2019
    FDA Expands RCT DUPLICATE Project
  • Apr 12, 2019
    Small Survey Finds GBM Patients Can’t Find Trials
  • More

U.S. Food Labeling

  • Apr 19,2016
    Sen. McCaskill Prods FDA on Products Containing Oxilofrine
  • Apr 14,2016
    FDA Warns Supplement Makers for Using Non-Dietary Ingredient
  • Apr 7,2016
    Failure To Declare Presence of Allergens Leads to Two Product Recalls
  • Mar 31,2016
    Trader Joe’s Recalls Flavored Chocolate Sticks Due to Mislabeling
  • Mar 21,2016
    Court Prohibits New York City’s Sodium Labeling Mandate
  • Mar 21,2016
    Court Dismisses Coffee-Mate Labeling Suit
  • Mar 21,2016
    FDA Again Delays Enforcement of Menu Labeling Rule
  • Mar 16,2016
    Bakery Recalls Sandwiches Due to Third-party Error
  • Mar 8,2016
    Vilsack Prods Senate to Pass GE Labeling Bill
  • Mar 7,2016
    Food Boxes Recalled Over Allergy Concerns
  • More

FDA Regulation & Enforcement

  • Sep 1, 2022
    Court Rejects FDA’s Attempt To Regulate Procedures Performed by California Stem Cell Clinic
  • Sep 1, 2022
    Studies Look at Market Effect of Mandated GMO Labeling Under Vermont Law
  • Aug 31, 2022
    N.C. Device Maker Agrees To Pay Over $785,000 To Resolve Allegations of False Medicare Coding
  • Aug 29, 2022
    Court Allows Federal FCA Case Against Abbott to Proceed
  • Aug 24, 2022
    Optical Lens Maker To Pay $22 Million To Resolve False Claims Liability Tied to Alleged Kickbacks
  • Aug 23, 2022
    Consent Decree Bars Illinois Pharmaceutical Company From Manufacturing, Marketing Adulterated Drugs
  • Aug 22, 2022
    Study Finds DTC Heart Drug Ads Have Little Effect on Lifestyle Intentions
  • Aug 18, 2022
    Doctor Convicted on Misbranding Charge for Marketing Unapproved Substance Used for Weight Loss
  • Aug 18, 2022
    FDA Finalizes Guidance on Supplements Containing NAC
  • Aug 14, 2022
    Risk Info in CSL Communications Aids Consumer Recognition, Study Finds
  • More

Medical Devices

  • Dec 21, 2018
    CDRH Researchers Examine Virtual Trials for Regulatory Evaluation of Imaging Devices Trials
  • Dec 20, 2018
    Finalized Guidance on FDA’s Breakthrough Devices Program Outlines Options for Product Developers
  • Dec 20, 2018
    FDA Finalizes Guidance on When To File a PMA Supplement for a Manufacturing Site Change
  • Dec 18, 2018
    FDA Finalizes Rule for Device Classification Procedures, Drops Proposed Device Class Redefinitions
  • Dec 17, 2018
    Olympus Medical Systems, Former Top Regulatory Official Plead Guilty to Medical Device Report Violations
  • Dec 13, 2018
    FDA Recognizes Public Genetic Variant Database To Support Premarket Submissions for New Genetic Tests
  • Dec 5, 2018
    FDA Issues Proposed Rule for De Novo Classification Process That Would Establish Submission Requirements
  • Dec 5, 2018
    ev3 Inc. Pleads Guilty to Adulteration Charge Related to Off-Label Promotion of Neurovascular Device
  • Nov 28, 2018
    FDA Outlines Sweeping 510(k) Reforms Intended To Steer Manufacturers Toward Continual Innovation
  • Nov 26, 2018
    CDRH Plans To Improve Device Trial Patient Engagement
  • More

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