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Advertising & Promotion

  • May 4, 2019
    Insys Founder, Four Former Executives Found Guilty of RICO Conspiracy
  • May 4, 2019
    Hospitals Sue Over Opioid Marketing
  • Apr 29, 2019
    Two Drug Companies To Pay $125 Million To Resolve Kickback Allegations Involving Co-pay Assistance
  • Apr 26, 2019
    Connecticut Files Amended Lawsuit Against Purdue Pharma
  • Apr 23, 2019
    J&J To Pay $9.9 Million To Settle Washington Suit Over Disclosure of Surgical Mesh Risks
  • Apr 22, 2019
    OPDP-RTI Review of DTC Studies Finds Both Potential Benefits and Harms
  • Apr 11, 2019
    Three Drug Makers To Pay a Total of Over $122 Million To Resolve Foundation Co-pay Coverage Allegations
  • Apr 10, 2019
    House Ways and Means Committee Approves STAR Act
  • Apr 10, 2019
    Indivior Indicted for its Marketing of Suboxone Film
  • Apr 10, 2019
    Sample Accounting Bill Introduced in House
  • More

Good Clinical Practice

  • Jun 17, 2019
    Seven New SACHRP Members Named
  • Jun 14, 2019
    Senate Bill Would Require Cost Reporting; Provide Funds for Clinical Trials
  • Jun 12, 2019
    Health Canada Changes Stance on ‘Off-label’ Use of Drugs in Clinical Trials
  • Jun 10, 2019
    Four Drug Companies Join with Verily To Streamline Clinical Research
  • Jun 10, 2019
    Aversion to Randomization Could Be Factor in Low Trial Participation
  • Jun 10, 2019
    Number of FDA BIMO Inspections Jumps Significantly in FY 2018
  • Jun 10, 2019
    FDA Sets Two-Day Workshop on Leveraging Trials To Generate RWE
  • Jun 8, 2019
    FDA Issues Draft Guidance for Broadening Trial Eligibility Requirements To Aid Inclusion
  • Jun 8, 2019
    CDER Provides Guidance on Phase 3 NASH Trials
  • Jun 8, 2019
    ACRP Joins with APEIC To Validate Clinical Research Competency in Latin America
  • More

U.S. Food Labeling

  • Sep 14,2016
    FDA Issues Draft Guide on Evidence Needed to Support Structure/Function Claims on Infant Formula
  • Sep 7,2016
    Cheese Maker Warned for Misleading Labeling Claims
  • Aug 31,2016
    ANPR on Mandatory GMO Labeling Coming Soon, AMS Says
  • Aug 25,2016
    Two Bakeries Issue Recalls Due to Undeclared Allergens
  • Aug 18,2016
    FDA’s Final Rule on GRAS Already Facing Criticism
  • Aug 17,2016
    Revised Draft Guidance on NDI in Supplements Issued
  • Aug 3,2016
    FDA Extends Deadline for FOP-Labeled Items Sold in Vending Machines
  • Jul 31,2016
    Mandatory GMO Labeling Now Law Nationwide
  • Jul 28,2016
    Labeling Errors Lead to Recall of Shrimp Product, Salads
  • Jul 19,2016
    NuTek Food Science Asks FDA for Guidance on Potassium Salt
  • More

FDA Regulation & Enforcement

  • Nov 17, 2022
    FDA Allows Makers of Six COVID-19 Drugs To Provide Safety, Efficacy Results in Promotional Material
  • Nov 17, 2022
    Charity Asks Court To Nullify HHS OIG Advisory Opinion on Kickback Implications of Cancer Drug Help
  • Nov 10, 2022
    Court Enjoins Distribution of Adulterated, Misbranded Supplements
  • Nov 9, 2022
    Former Physician, Former Pharma Sales Rep Plead Guilty to Charges Related to Compounded Drug Scheme
  • Nov 6, 2022
    Study: More Than a Third of Physicians, APCs Receive Industry Payments
  • Nov 3, 2022
    Doctor, Avanir Sales Rep Plead Guilty to Fraud Conspiracy Charges Stemming from Kickback Scheme
  • Nov 1, 2022
    IFPMA and EFPIA Provide Advice on Use of Social Media
  • Oct 27, 2022
    Former Cereal Manufacturer QA Director Pleads Guilty to Adulteration Charges Linked to Salmonella Outbreak
  • Oct 27, 2022
    FDA Officials Explain Need for ‘Healthy’ Labeling Proposal, FOP Labeling
  • Oct 27, 2022
    Lower Percentage of OPDP Core Launch Reviews Met 45-Day Goal During FY 2022
  • More

Medical Devices

  • May 16, 2019
    Utah Court: Some Claims Brought Against Maker of 510(k)-Cleared Contact Lens Solution Are Preempted
  • May 9, 2019
    FDA Begins Sunsetting Its Alternative Summary Reporting Program for Medical Device Reports
  • Apr 30, 2019
    FDA Recommends How To Present Nonclinical Bench Performance Testing Information in Submissions
  • Apr 29, 2019
    Grassley, Wyden Question Physician-Owned Distributorships’ Compliance with Sunshine Act Reporting Mandates
  • Apr 29, 2019
    Final UDI Guidance on Convenience Kits Seeks To Clarify FDA Policy on Medical Procedure Kits
  • Apr 24, 2019
    Draft FDA Guidance Shows How Companies Should Prepare for, Initiate Voluntary Product Recalls
  • Apr 22, 2019
    Draft Guidance from CDRH Offers Premarket Submission Recommendations for Quantitative Imaging Devices
  • Apr 18, 2019
    FDA Finalizes List of Eight Distinct Medical Device Accessory Types Suitable for Class I
  • Apr 8, 2019
    FDA Looks to ‘Tailored Review Framework’ for Devices Using Artificial Intelligence, Machine Learning
  • Apr 3, 2019
    FDA Updates Device Establishment Inspection Processes, Standards in Response to FDARA Mandate
  • More

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