Search Results for:
Frederick R Ball
(86)
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ARTICLES(86)
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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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FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs
- January 12, 2017
- 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FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act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
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CMS Delays Data Collection Under ACA's Physician Payments Sunshine Act to January 1, 2013
- May 10, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court Addresses Whether Supremacy Clause Provides Private Right of Action to Challenge Medicaid Cuts in Douglas v. Independent Living Center
- March 14, 2012
- LEGAL ALERTS/ARTICLES
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Centers for Medicare and Medicaid Services Releases Proposed Rule on Reporting and Returning of Overpayments
- March 13, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Draft Guidance for Notification of Issues That May Result in Prescription Drug Shortage
- March 06, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Proposed Rule Regarding Citizen Petitions and PSAs Related to Section 505(b)(2) Applications or ANDAs
- January 06, 2012
- LEGAL ALERTS/ARTICLES
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Illinois Broadens the Standards for Enforcing Restrictive Covenants in Illinois
- December 09, 2011
- LEGAL ALERTS/ARTICLES
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FTC Steps Up Enforcement on Health-Related Claims in Advertising
- November 08, 2011
- LEGAL ALERTS/ARTICLES
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New FDA Guidance for Industry on Implementation of Fee Provisions of the Food Safety Modernization Act
- October 12, 2011
- LEGAL ALERTS/ARTICLES
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FDA Issues Compliance Policy Guide That Provides Potential Business Advantage for Filing New Drug Application for Marketed, Unapproved Drug
- October 10, 2011
- LEGAL ALERTS/ARTICLES
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FDA Publishes Final Guidance for Industry on Applications for Nonprescription Drug Products
- October 10, 2011
- LEGAL ALERTS/ARTICLES
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U.S. District Judge Rejects FDA’s Attempted Regulatory Authority over Compounding Pharmacies in United States v. Franck's Lab, Inc.
- September 22, 2011
- LEGAL ALERTS/ARTICLES
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FDA Issues Proposed Rule to Withdraw Regulations Related to Prescription Drug Marketing Act Pedigree Requirements
- July 25, 2011
- LEGAL ALERTS/ARTICLES
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U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers
- June 28, 2011
- LEGAL ALERTS/ARTICLES
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CMS: Proposed Rule for States on Medicaid Fee-for-Service Rate-Setting Procedures
- May 17, 2011
- LEGAL ALERTS/ARTICLES
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FDA: Liquid OTC Drugs with Poorly Labeled Measuring Devices May Constitute Misbranding
- May 16, 2011
- LEGAL ALERTS/ARTICLES