debarment certification fda

115 results for debarment certification fda

  • vLex Rating
  • False Claims Act: 2017 Year-in-Review

    False Claims Act (FCA) recoveries topped $3.7 billion in fiscal year 2017, marking the eighth straight year of annual recoveries in excess of $3 billion. Healthcare cases, including ones involving drug and device companies, accounted for most of the total, at roughly $2.47 billion. Recoveries in Defense Department cases increased to approximately $220 million, nearly double the 2016 figure, and...

  • Fighting the battle against health care fraud: federal enforcement actions.

    ... all defendants by way of suspended payments, compliance, and debarment actions. . Facing this diverse group of adversaries, the health care ...Testimony cannot be compelled, except to obtain a certification upon production that the requested documents are complete, accurate, and ...

  • False Claims Act: 2016 Year-in-Review

    In 2016, the Department of Justice (DOJ) continued to give high priority to False Claims Act (FCA) investigations and prosecutions. The government brought in more than $4.76 billion in settlements and judgments, nearly a billion dollars more than the previous year. Healthcare cases, including ones involving drug and device companies, again accounted for the lion’s share at roughly $2.6 billion....

  • California Lawyer 2015 Roundtable Series – False Claims Act

    False Claims Act practice is evolving in subtle ways that may particularly affect cases where the federal government does not intervene. Recent decisions help clarify the law’s “first-to-file” rule and who may pursue allegations that entities have made false claims for government funds. Other especially noteworthy developments so far this year include the U.S. Supreme Court’s ruling in KBR v. ex...

  • Health Update - September 2015

    Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face increasing exposure under the federal False Claims Act (FCA), 31 U.S.C. §§ 3729–3733. Generally, the FCA imposes liability on persons or entities who knowingly (w

    ...§ 287 and/or suspension/debarment from government contracting. . . Damages and Penalties . . The FCA ..., which were rendered "false" due to the implied certification, made by every claimant under a federal program, that the claim is not ...

  • MoForward 2018

    On Thursday, October 26th, Morrison Foerster’s Government Contracts Group held its inaugural MoForward Event at the Tysons Corner Ritz Carlton. The event was a rousing success, reflecting the unique interaction between our deep government contracts bench and our colleagues who have led the government’s and industry’s most significant enforcement and response teams. The full day program

  • 2019 Antitrust Year in Review

    Wilson Sonsini Goodrich & Rosati (Wilson Sonsini) is pleased to present its 2019 Antitrust Year in Review, which summarizes the most significant antitrust matters and developments of the past year. Over the past few years, the use of antitrust laws and regulations has become a highly debated subject in public discourse, and this year saw antitrust become the fashionable tool to cite on a wide

  • Government Contracts Quarterly Update - July 2014

    The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. Topics will include: - Proposed Rule Focuses on Audit of Business Systems, May Expedite and Streamline Process - D.C....

  • Government Contracts Quarterly Update - February 2014

    The Government Contracts Quarterly Update is published by BakerHostetler's government contracts practice group to inform our clients of the latest developments in federal government contracting. This update covers the following topics: - Counterfeit Parts - Cybersecurity - False Claims Act - Whistleblower Protections - ...

  • Government Contracts Quarterly Update - May 2015

    The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. Topics in the current issue include: - DoD Issues Final Rule Expanding Contractor Duties Regarding Personally Identifiable Information &

  • Moforward 2020: Need-To-Know Regulatory and Legal Developments

    BID PROTESTS, LATEST DEVELOPMENTS & TWISTS - Bid Protests: Agenda - 1. LOGCAP V and Task/Delivery Order Protest Jurisdiction 2. SpaceX and Other Transaction Authority Protest Jurisdiction 3. Potential Impact of New LPTA Regulations 4. Section 809 Panel Recommendations: Real Changes for Protests(?) Please see full Presentation below for more...

  • The Hazy Rollout of Ohio’s Medical Marijuana Control Program (MMCP)

    When Ohio House Bill 523 (HB 523) became effective on September 8, 2016, Ohio joined the company of 25 other states, the District of Columbia, and several U.S. territories that have legalized cannabis for medicinal purposes. Modeled after highly restrictive regimes adopted by state legislatures in Illinois, Maryland, and New York, the Medical Marijuana Control Program (MMCP) envisioned by HB 523...

  • Government Contracts Quarterly Update - January 2015

    The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. Topics in the current issue include: - Bid Protests: Court of Federal Claims Bid Protest Jurisdiction Limited - Contract...

  • False Claims Act: 2015 Year-in-Review

    In 2015, the Justice Department (DOJ) continued to give high priority to False Claims Act (FCA) investigations, bringing in nearly $3.6 billion in settlements and judgments. More than 630 qui tam suits were filed. DOJ's leadership made clear that in 2016 FCA investigations will increasingly focus on individual as well as organizational defendants and pursue potential criminal as well as civil...

  • Global Government Solutions® 2016 Mid-Year Outlook

    This newest edition of the Global Government Solutions® series highlights increased government involvement in global commerce and provides the latest regulatory information corporate leaders need to navigate the intersection of business and government. The 2016 Mid-Year Outlook includes a diverse collection of over 40 articles from practitioners across our global platform...

  • Individual Liability: What’s Behind The Headlines?

    It’s been open season on financial institutions since the 2008-2009 financial crisis (“Financial Crisis”). State and federal prosecutors and regulators are competing with each other for press coverage of their latest consent order trophies, which include assessments of unprecedented civil money penalties and restitution orders. This focus on “accountability” has gone beyond the institutions, to...

  • False Claims Act: 2019 Year-in-Review

    The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar, standards for determining the materiality of allegedly false claims, the standard of review for government motions dismiss under 31 U.S.C. § 3130(c)(2)(A), and the definition of...