Search Results for:
Hyman Phelps Mcnamara Pc
(762)
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ARTICLES(762)
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A Second Company Asks FDA to Reconsider Denial of NCE Exclusivity for Approved FDC . . . and to Stay Application of the Agency’s New Interpretation
- April 23, 2014
- LEGAL ALERTS/ARTICLES
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Proposed GMO Labeling Bill Would Block State Laws
- April 21, 2014
- LEGAL ALERTS/ARTICLES
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Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER
- April 21, 2014
- LEGAL ALERTS/ARTICLES
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Setting the Record Straight on GRAS: Part 1
- April 16, 2014
- LEGAL ALERTS/ARTICLES
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FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation
- April 15, 2014
- LEGAL ALERTS/ARTICLES
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GPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation
- April 15, 2014
- LEGAL ALERTS/ARTICLES
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When is a Thick Sweet Syrupy Substance Properly Labeled as Honey?
- April 15, 2014
- LEGAL ALERTS/ARTICLES
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Another REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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D.C. Circuit to Hear COOL Case En Banc
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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Proposed Federal Legislation Aims to Speed Up DEA’s Scheduling of New Medicines and Approval of DEA Registrations in Certain Circumstances
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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A Second Lawsuit Tests the BPCIA Biosimilars “Patent Dance” Waters
- April 04, 2014
- LEGAL ALERTS/ARTICLES
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Evaporated Cane Juice Case Evaporates (For Now)
- April 04, 2014
- LEGAL ALERTS/ARTICLES
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FDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop
- April 04, 2014
- LEGAL ALERTS/ARTICLES
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FDA Issues Proposed Rule Amending Classification and Reclassification Regulations for Medical Devices (21 C.F.R. Part 860)
- April 03, 2014
- LEGAL ALERTS/ARTICLES
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FDA Expands Electronic Safety Reporting for Animal Food
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Independent Innovator and Repurposing Act Would Create New Patent Term Extension for Certain Biologics Patents
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Limitations Imposed on Use of FDA Warning Letters
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows
- March 20, 2014
- LEGAL ALERTS/ARTICLES
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NAD Advertising Policy Purposefully Differs from FTC Legal Standards for Substantiation
- March 19, 2014
- LEGAL ALERTS/ARTICLES
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Proposed Sunscreen Innovation Act to Speed up FDA’s Review of Time and Extent Applications for Sunscreen Ingredients
- March 19, 2014
- LEGAL ALERTS/ARTICLES
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State Marijuana Initiatives Put U.S. in the Hot Seat with the INCB
- March 19, 2014
- LEGAL ALERTS/ARTICLES
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Court Rules that FTC’s Substantiation Requirements Are Applicable to Claims for Medical Foods
- March 17, 2014
- LEGAL ALERTS/ARTICLES
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FDA Sued Over Failure to Issue Export Certificate
- March 17, 2014
- LEGAL ALERTS/ARTICLES
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Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA
- March 12, 2014
- LEGAL ALERTS/ARTICLES
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Amicus Filings in POM Wonderful’s Lanham Act Case Reflect Myriad of Views on Proper Interaction Between the FDC Act and Lanham Act
- March 12, 2014
- LEGAL ALERTS/ARTICLES
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FDA Requests Input Regarding Re-engineering of the 40 Year Old OTC Monograph Process
- March 12, 2014
- LEGAL ALERTS/ARTICLES
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Generic Drug Labeling Preemption: The Flavor of the Day
- March 12, 2014
- LEGAL ALERTS/ARTICLES