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Advertising & Promotion

  • May 14, 2019
    Five Insys Executives Convicted of Racketeering Conspiracy for Bribes Provided to Subsys Prescribers
  • May 10, 2019
    PhRMA Launches Drug Price Website
  • May 10, 2019
    N.J. Amends Regulation Limiting Meal Costs
  • May 8, 2019
    Many Question CMS’ Authority To Promulgate Rule
  • May 8, 2019
    CMS Examines First Amendment Concerns Over Final Rule Requiring Pricing Information in DTC TV Ads
  • May 8, 2019
    FDA Moves Ahead with Study of DTC Disclosures for Accelerated Approval Products
  • May 8, 2019
    CMS Publishes Final Rule Requiring Pricing Info in DTC TV Drug Ads
  • May 8, 2019
    Unsealed Qui Tam Suit Alleges Off-Label Marketing
  • May 6, 2019
    Bill Prohibiting Drug Advertising Introduced in Maine Senate
  • May 6, 2019
    Specialty Drug Company Will Pay $17.5 Million To Settle Kickback Allegations
  • More

Good Clinical Practice

  • Jun 30, 2019
    Patient Preferences Should Be Considered in Noninferiority Clinical Trials
  • Jun 30, 2019
    CDRH Issues Draft Guidance on Clinical Investigations for Prostate Tissue Ablation Systems
  • Jun 29, 2019
    N.C. Governor Signs Bill Expanding Right-to-Try To Investigational Adult Stem Cell Treatments
  • Jun 29, 2019
    FDA Hosts Workshop on Endpoints for Heart Failure Drug Development
  • Jun 28, 2019
    FDA Releases Draft ICH Guidance on Using a Selective Approach To Safety Data Collection
  • Jun 27, 2019
    CBER Plans Guidance on Interacting with the Agency on Complex Trial Designs
  • Jun 27, 2019
    Lack of Protocol Info Limits Trial Referrals from Front-line Physicians
  • Jun 20, 2019
    ACRP Releases Core Competency Guidelines for Clinical Trial Investigators
  • Jun 19, 2019
    UK Opens Consultation on Trial Transparency
  • Jun 19, 2019
    FDA Offers Clinical Investigator Training
  • More

U.S. Food Labeling

  • Nov 16,2016
    Guidance Finalized for Voluntary Program Designed To Expedite Review, Importation of Food Products
  • Nov 9,2016
    FDA Seeks Comment on RACC for Certain Spreads
  • Oct 26,2016
    Pulled Pork, Chicken and Dumplings Products Recalled
  • Oct 20,2016
    Taiwanese Noodle Maker Warned over Coloring Additives
  • Oct 19,2016
    Kraft Recalls Snack Products, Citing Labeling Error
  • Oct 11,2016
    PepsiCo Faces Lawsuit Over Naked Juice Labeling
  • Sep 29,2016
    Florida Consumer Protection Suit Against Gerber Dismissed
  • Sep 28,2016
    FDA To Use Enforcement Discretion on Use of ‘Healthy’ Claim
  • Sep 19,2016
    DOJ Sues to Stop Acquisition of Monsanto Unit
  • Sep 19,2016
    California Judge Tosses False Labeling Suit Against Tea Maker
  • More

FDA Regulation & Enforcement

  • Dec 19, 2022
    FDA: Ads for Hypertension Drugs Should Cite Cardiovascular Outcome Claims
  • Dec 15, 2022
    FDA Guidance on Inspection Refusals That Can Deem a Drug Adulterated Is Updated To Include Devices
  • Dec 15, 2022
    PMCPA Finds Novo Nordisk Breached ABPI Code in Weight Management Course Sponsorship
  • Dec 9, 2022
    FDA Posts Clarifying Guidances on Food Allergen Labeling, Asks for Comments on 'Milk,' 'Eggs'
  • Dec 7, 2022
    Final FDA Guidance Identifies Types of Homeopathic Drugs Targeted for Prioritized Enforcement Action
  • Dec 1, 2022
    Teva and Allergan Agree to Nationwide Opioid Marketing Settlements
  • Nov 30, 2022
    Drug Official Convicted Under Park Doctrine Asks Court To Toss HHS Five-Year Mandatory Exclusion
  • Nov 24, 2022
    PhRMA Backs Pfizer’s Petition Seeking Supreme Court Review of Second Circuit's Approval of HHS OIG Advisory Opinion on Kickbacks
  • Nov 23, 2022
    Cell Culture Food Gets First FDA Safety Go-Ahead
  • Nov 17, 2022
    Court Dismisses Patient’s 17 State Law Claims Against Maker of Essure Birth Control Device
  • More

Medical Devices

  • Jul 3, 2019
    Final Rule Sets Time Frames for CDRH Review of Agency’s ‘Significant Decisions’ About Medical Devices
  • Jun 30, 2019
    CDRH Issues Draft Guidance on Clinical Investigations for Prostate Tissue Ablation Systems
  • Jun 26, 2019
    Guidance Outlines FDA’s Recommendations for 510(k) Submissions for Diagnostic Ultrasound Technology
  • Jun 20, 2019
    Senate Bill Would Mandate Rules Guarding Privacy of Personal Data in Apps, DNA Tests, Wearable Devices
  • Jun 13, 2019
    ACell Inc.’s Failure To Report Removal of Wound Dressing Product to FDA Leads to $15 Million Settlement
  • Jun 6, 2019
    Second Circuit: Patient’s Tort Claims Related to Allegedly Defective Implants Untimely Under New York Law
  • May 29, 2019
    Court: State Law Tort Claims Related to Knee Implant Device Approved Through PMA Are Preempted
  • May 28, 2019
    New DOJ Corporate Compliance Program Guidance Shows How Prosecutors Scrutinize Companies’ Compliance Efforts
  • May 23, 2019
    CDRH Calls for Companies To Volunteer To Participate in Test Plan for Software Pre-Cert Program
  • May 16, 2019
    Supreme Court Takes Expansive View of False Claims Act’s Statute of Limitations Requirements
  • More

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