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    Some Holiday Cheer! FDA Law Blog Chosen as One of the ABA Journal’s Blawg 100

    …from Abbott Point of Care in Ottawa, Canada.  “We all have access to similar information from the government (e.g., FDA draft guidances, etc.) but this blog not only explains the…

    cGMP Problems Shrink the DepoCyt Chemotherapy Market

    In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising…

    Petition to Bar Hydroponic Operations from Organic Certification

    The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995. In most countries, such as Mexico and Canada, and regions,…

    FDA Proposes to Nix Use of Nutrient Content Claims for EPA and DHA

    …(the “Martek notification,” effective since May 22, 2005); and a notification concerning nutrient content claims for DHA and EPA submitted by Ocean Nutrition Canada, Ltd (permitted since April 9, 2006…

    Court Finds D.C. Law Prohibiting Patented Drugs from Being Sold for an Excessive Price Preempted by Federal Patent Law

    …price in any “high income country” (defined in the Act as the U.K., Germany, Canada, and Australia), the manufacturer was presumed to be in violation of the law.  The burden…

    The FTC’s Latest Patent Settlement Report Will Serve as Fodder for the Commission’s Crusade Against Patent Settlement Agreements

    …the Royal Bank of Canada and Jonathan Orszag, former Director of the Office of Policy and Strategic Planning and member of President Clinton’s National Economic Council – supporting the proposition…

    Are Predetermined Change Control Plans on the road to Global Harmonization?

    …(PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. See our prior blog post on the topic here. FDA announced that FDA, Health Canada, and MHRA are jointly publishing guiding principles…

    What is Beef? Round Two

    …regulatory framework, if any exists for cell-cultured food products and how this framework compares to other international approaches,” e.g., those in Canada, Japan, and the European Union. According to the…

    Hyman, Phelps & McNamara, P.C. Takes Top Honors in Two Prestigious Categories in 2023 LMG Life Sciences Awards

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    International Plan of Mystery: ICH Guidelines for Generic Drugs

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    NRDC Citizen Petition Requests that FDA Prohibit All Use of Bisphenol A as a Food Additive

    …regulatory agencies in the United States, Canada, Europe, and Japan . . . that current levels of exposure to BPA through food packaging do not pose an immediate health risk.”…

    FDA Inspections: Lesson 1 – Interviewing Employees

    …Ontario, Canada, citing it for limiting and delaying FDA’s inspection based on the following conduct: The Quality Manager “shoving and shouting at our investigators for conducting the inspection without [his]…

    House Passes FDA Appropriations Bill With Drug Importation Provision

    …a February 2003 letter issued in response to inquiries about the liability of various parties involved in importing prescription drugs from Canada.  FDA’s letter states: The reason that Canadian or…

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

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    FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

    …a citizen petition originally submitted in 2013 by anti-tobacco and public health groups (including prominent African American groups like the African American Tobacco Control Leadership Council) on prohibiting menthol cigarettes….

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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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