FDA Regulatory and Compliance Monthly Recap

Wednesday, March 1, 2017

Source: Loeb & Loeb LLP

Loeb & Loeb's FDA Regulatory and Compliance Monthly Recap is now available for the month of February. This report recaps the past month's key legal news, updates and regulatory developments impacting health and life sciences companies that manufacture or distribute FDA-regulated products.

You can read, download and print the report by clicking on the link provided here:
FDA Regulatory and Compliance February 2017 Recap

Key Findings in This Issue:

  • FDA's enforcement stats paint opposing pictures for pharmaceuticals, medical devices
  • Industry groups say final rule on intended use establishes unfounded legal standard, call for indefinite stay
  • President Trump signs 'two out, one in' executive order with implications for FDA
  • FDA issues warning letter to Fresenius subsidiary over misleading promotional material

About Loeb & Loeb LLP's FDA Regulatory and Compliance Practice

Loeb & Loeb's FDA Regulatory and Compliance Practice comprises an interdisciplinary team of regulatory, corporate, capital markets, patent and litigation attorneys who advise clients on the full spectrum of legal and business issues related to the distribution and commercialization, including marketing and promotion, of FDA-regulated products. Focusing on the health and life sciences industries, including pharmaceuticals, biologics, medical devices, wellness products, dietary supplements and organics, the practice counsels clients on regulatory issues, compliance-related matters and risk management strategies; advises on laws and regulations related to product advertising and labeling; counsels on FDA exclusivity policies and related Hatch-Waxman issues; and provides representation in licensing transactions and regulatory enforcement actions.

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