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    A Final LDT Rule in April!? Will FDA be Prepared?

    …how many comments were actually logged in; on December 7, FDA showed 19,655 comments, and the next day 6,732.) While some comments were boilerplate, others were comprehensive, detailed critiques of…

    U.S. Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims

    …and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have…

    FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests

    …180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….

    FTC codifies its Enforcement policy for “Made in the USA” Claims; False “Made in the USA” Claims May Now Result in a Monetary Penalty

    On July 1, 2021, the Federal Trade Commission (FTC) announced the availability of the pre-publication of the final rule on “Made in USA” (MUSA) claims in the Federal Register. The…

    FTC Announces a Proposed Rule for Made in the USA; Does It Go Beyond Its Authority?

    …to be a popular advertising claim. Generally, FTC enforcement actions regarding unqualified Made in the USA claims have been limited to closing letters and orders enjoining companies from making false…

    Oh Canada! Drug Importation Bills Look North to Address Accessibility and Cost

    …Horton’s from Canada. On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was…

    Petition for Formal Rule re Made in USA Claims

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    Challenges Face New Federal Drug Importation Law

    …an interim order banning the export of certain drugs from Canada. The Final Rule As discussed in our prior post, the Final Rule implements Section 804 of the Federal Food,…

    Disclosures in a Small Space: The FTC’s Revisions to .Com Disclosures

    Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones…

    FSIS Admits Its Policy for Product of USA Labeling is Misleading; Will Undertake Rulemaking

    …and here for our blog posts). In 2018, the Organization for Competitive Markets and the American Grassfed Association requested that FSIS revise its policy on “Product of USA” claims so…

    Google to pay $500 Million Regarding Pharmacy Advertising; What is Next?

    …process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…

    COPPA at 16

    …under 13; and Companies that have actual knowledge that they are collecting PI via another company’s website or online service that is directed to children. If a company is covered…

    FTC Could Revise its Dot Com Disclosures Guidelines by Fall 2012

    …There were a few presentations that included research and data on how consumers read disclosures online, and the innovative techniques that some companies are creating to effectively communicate disclosures (including…

    Will FDA’s Section 804 “Enhancements” Really Speed Up Drug Imports from Canada?

    …President Trump’s April 15 Executive Order (EO), “Lowering Drug Prices by Once Again Putting Americans First. That EO provided that within 90 days, “the Secretary, through the Commissioner of Food…

    HHS and FDA Finalize Drug Importation Rule and Guidance for New Multi-Market Approved (MMA) Product Category; CMS Provides Guidance for MMA Products under the Medicaid Drug Rebate Program

    …Importer that will buy the drug directly from the Foreign Seller. The Foreign Seller must be licensed by Health Canada as drug wholesalers and registered with FDA as a Foreign…

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  • Recent Posts
    • The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements? July 3, 2025
    • HP&M Seeks Experienced Regulatory Expert July 2, 2025
    • Controlled Substance Reporting Isn’t Just for DEA Anymore July 1, 2025
    • The RFD Process: Time for Reform? June 30, 2025
    • New Report on Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry June 26, 2025
  • Trackers
    • 180-Day Exclusivity Tracker
    • FDA Citizen Petition Tracker
    • REMS Tracker (Historical – Not Recently Updated)
    • FDA Legislation Tracker
  • Orange Book Archives

     

    ANDA Paragraph IV Patent Certifications List Archives

  • Scorecards
    • Generic Drug Labeling Carve-Out Scorecard
    • Biosimilars State Legislation Scorecard (Historical – Not Recently Updated) 
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    • Big Molecule Watch Blog
    • Bloomberg BNA Health Care Blog
    • Drug and Device Law Blog
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    • Internet Drug News.com
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