Search Results for:
Duane Morris Llp
(112)
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ARTICLES(112)
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CMS Issues Proposed Regulations to Expand Open Payments System Reporting
- August 26, 2019
- LEGAL ALERTS/ARTICLES
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FDA Releases Guidance on REMS Modifications and Revisions
- August 09, 2019
- LEGAL ALERTS/ARTICLES
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Second Circuit Asks How to Address 924(c) Appeals in the Wake of Davis
- August 07, 2019
- LEGAL ALERTS/ARTICLES
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FDA Comments on the Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds and Extends Comment Period
- June 24, 2019
- LEGAL ALERTS/ARTICLES
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Diversity on Corporate Boards: A Tortuous Path
- May 28, 2019
- LEGAL ALERTS/ARTICLES
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Massachusetts Employers: Are You Ready for Paid Family and Medical Leave?
- May 17, 2019
- LEGAL ALERTS/ARTICLES
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CDER's New MAPP on Risk-Based Site Selection Model for Routine Inspections
- January 15, 2019
- LEGAL ALERTS/ARTICLES
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FDA Issues Final Guidance on Data Integrity and Compliance with CGMP
- January 14, 2019
- LEGAL ALERTS/ARTICLES
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DOJ Implements Granston Memo: Motions to Dismiss Filed in 11 False Claims Act Cases
- January 03, 2019
- LEGAL ALERTS/ARTICLES
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FDA Announces New UDI Compliance Deadlines via Another Guidance Document
- December 27, 2018
- LEGAL ALERTS/ARTICLES
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FDA Provides Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals
- November 27, 2018
- LEGAL ALERTS/ARTICLES
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Redraft of 510(k) Third Party Review Program
- November 08, 2018
- LEGAL ALERTS/ARTICLES
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Ten Years of MedImmune: How License Agreements Changed
- April 12, 2017
- LEGAL ALERTS/ARTICLES
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Second Circuit Reverses Lower Court's Restrictions on the Restructuring of Bondholder Rights in Marblegate
- March 09, 2017
- LEGAL ALERTS/ARTICLES
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First Circuit Bankruptcy Appellate Panel Latest to Warm Up to Protections for Trademark Licensees in Bankruptcy
- January 17, 2017
- LEGAL ALERTS/ARTICLES
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FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs
- January 12, 2017
- LEGAL ALERTS/ARTICLES
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Massachusetts Trial Court Showing Deference to Arbitration as Sutow and Harelick Decisions Hew to Policy Favoring Arbitration
- January 19, 2016
- LEGAL ALERTS/ARTICLES
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Personnel Files and Documents Relating to "Hand-Picked" Directors Ruled Discoverable in Breach of Fiduciary Duty Action Against Private Equity Firm
- November 30, 2015
- LEGAL ALERTS/ARTICLES
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Bank Leumi Agreement with Department of Justice Results in Disclosure of Identities of 1,500 U.S. Account Holders
- February 17, 2015
- LEGAL ALERTS/ARTICLES
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Compounding Pharmacy Co-Owner Pleads Guilty to Misdemeanor Criminal Violations of the Food, Drug, and Cosmetic Act
- January 19, 2015
- LEGAL ALERTS/ARTICLES
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FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)
- January 19, 2015
- LEGAL ALERTS/ARTICLES
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FDA's Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection
- January 19, 2015
- LEGAL ALERTS/ARTICLES
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FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
- December 10, 2014
- LEGAL ALERTS/ARTICLES
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FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA
- November 17, 2014
- LEGAL ALERTS/ARTICLES
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U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies
- January 09, 2013
- LEGAL ALERTS/ARTICLES
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FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety Modernization Act of 2011
- December 03, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Guidance for Industry on Generic Drug User Fee Amendments of 2012: Q&A
- September 03, 2012
- LEGAL ALERTS/ARTICLES
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D.C. Circuit Affirms HHS Power to Disqualify Corporate Officials Convicted of Misdemeanors Under the "Responsible Corporate Official" (RCO) Doctrine
- August 13, 2012
- LEGAL ALERTS/ARTICLES
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FDA's Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013
- August 13, 2012
- LEGAL ALERTS/ARTICLES
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Third Circuit Holds That Settlement Agreements Containing Payments from the Innovator to the Generic Challenger May Violate Antitrust Laws
- July 24, 2012
- LEGAL ALERTS/ARTICLES