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  • Article

    New USPTO IDS Fees Raise Strategic Stakes For Biotech Filings

    Effective Jan. 19, 2025, the USPTO implemented a new fee framework for IDS submissions, charging up to $800 for applications that list more than 200 references.
    United StatesIntellectual Property
    Polsinelli PC
    Polsinelli PC
  • Article

    Blockchain+ Bi-Weekly

    The Blockchain Bi-Weekly presented by the Polsinelli Blockchain+ team is a rundown of some of the key stories in the Web3, blockchain and crypto ecosystems curated by our attorneys...
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
Article

New FDA Guidance Could Speed Biosimilar Approvals And Cut Costs

On Oct. 29, 2025, the FDA announced draft guidance on how it will assess biosimilar medicines. The 2025 Draft Guidance is intended to reduce the time and expense necessary...
United StatesFood, Drugs, Healthcare, Life Sciences
Polsinelli PC
Polsinelli PC
  • Article

    Federal District Court Rules Qui Tam Whistleblower Enforcement Of False Claims Act Unconstitutional

    On September 30, 2024, Judge Mizelle, a federal judge in the Middle District of Florida, ruled that the False Claims Act's ("FCA") qui tam enforcement provision is unconstitutional...
    United StatesGovernment, Public Sector
    Polsinelli PC
    Polsinelli PC
  • Article

    Sixth Circuit Holds The Line On FCA Qui Tam Challenges As Eleventh Circuit Looms

    The Sixth Circuit declined to entertain constitutional challenges to the FCA's qui tam provisions, emphasizing that binding circuit...
    United StatesGovernment, Public Sector
    Polsinelli PC
    Polsinelli PC
  • Article

    California's Amended Data Broker Registration Law

    In October 2023, California Governor Gavin Newsom signed Senate Bill (S.B.) 362 into law, amending California's data broker registration law. By January 31, 2024...
    United StatesPrivacy
    Polsinelli PC
    Polsinelli PC
  • Article

    Medicare Continues Its Updates To Provider Enrollment Policies As Part Of Efforts To Enhance Program Integrity And Transparency

    The Centers for Medicare & Medicaid Services ("CMS") continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Polsinelli PC
    Polsinelli PC
  • Article

    White House Draft EO Targets State AI Laws As New EO Emphasizes Security

    A leaked executive order targets over 1,000 state-level AI bills, including laws in California and Colorado, and calls for a centralized federal approach to AI governance.
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
  • Article

    Interactive Map Showing Which States Have Issued COVID-19 Executive Orders To Stay At Home And Limit Non-Essential Services And March 27, 2020 Update

    This afternoon the U.S. Senate met in a pro forma session and passed a nearly $500 billion "interim" COVID-19 stimulus package by voice vote.
    United StatesCoronavirus (COVID-19)
    Polsinelli PC
    Polsinelli PC
  • Article

    Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

    On February 6, 2024, the Federal Trade Commission ("FTC") commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Polsinelli PC
    Polsinelli PC
  • Article

    Federal Circuit Strikes Life Sciences Patent Over Insufficient Disclosure Of Particular Species

    The Federal Circuit held that general disclosure of any part of a compound may be insufficient to support a priority date for a specific species within the genus.
    United StatesIntellectual Property
    Polsinelli PC
    Polsinelli PC
  • Article

    FCA At A Crossroads: Eleventh Circuit Case Could Upend Qui Tam Actions

    The Eleventh Circuit heard oral argument in United States ex rel. Zafirov, an appeal from a district court decision holding the FCA's qui tam provisions unconstitutional...
    United StatesLitigation, Mediation & Arbitration
    Polsinelli PC
    Polsinelli PC
  • Article

    COVID-19 Executive Orders To Stay At Home And Limit Non-Essential Services – April 2, 2020

    By Thursday of this week, a significant majority of states had acted to instruct residents to stay at home and to close non-essential businesses in response to the spread of COVID-19.
    United StatesCoronavirus (COVID-19)
    Polsinelli PC
    Polsinelli PC
  • Article

    California Regulators Publish Highly Anticipated Draft Regulations On Mandatory Pre-Transaction Notices For Health Care Entities

    Last week, the Office of Health Care Affordability ("OHCA") published draft regulations to implement the requirements for California health care entities filing mandatory notices of material change under SB 184.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Polsinelli PC
    Polsinelli PC
  • Article

    Cybersecurity For Critical Infrastructure Update – Incident Response Improves, Industry Standards Evolve

    Critical infrastructure facilities are increasingly vulnerable to cybersecurity events, as demonstrated by the number of cyberattacks that have occurred this year against utilities...
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
  • Article

    Dealmakers Beware: The Biden Administration's Proposed Merger Guidelines Suggest That The Only "Good" Deal May Be No Deal At All

    The long-awaited newly proposed Merger Guidelines were finally released at the end of July, and the Department of Justice and Federal Trade Commission have shaken things up.
    United StatesCorporate/Commercial Law
    Polsinelli PC
    Polsinelli PC
  • Article

    The Best Laid Plans: SEC Announces Examination Priorities For Regulation Best Interest And Form CRS

    On June 5, 2019, the SEC adopted Regulation Best Interest, which establishes a new standard of conduct under the Securities Exchange Act of 1934 for broker-dealers and persons who are associated persons ...
    United StatesCorporate/Commercial Law
    Polsinelli PC
    Polsinelli PC
  • Article

    BitBlog Bi-Weekly Update - February 14, 2020

    In a possible homage to the PolsinelIi BitBlog, SEC Commissioner Hester Peirce, known by some as Crypto Mom, has revealed herself as a fellow fan of musically referent prose and has elected to dive into the details of ...
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
  • Article

    OCR Proposes Regulatory Facelift To The HIPAA Security Rule: Addressing The Current Cybersecurity Environment With More Specificity And Additional Requirements

    On January 6, 2025, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a "Notice of Proposed Rulemaking,"...
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
  • Article

    Proposed Digital Asset Market Structure Bill Could Give Regulatory Clarity; But Is It The Regulatory Clarity The Industry Wants?

    The Digital Asset Market Structure "(DAMS") discussion draft bill attempts to provide regulatory clarity on crucial blockchain industry issues.
    United StatesTechnology
    Polsinelli PC
    Polsinelli PC
  • Showing 301–320 of 347 results

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