Search Results for:
Hyman Phelps Mcnamara Pc
(762)
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ARTICLES(762)
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FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment
- January 07, 2013
- LEGAL ALERTS/ARTICLES
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DEA Proposes Disposal Regulations Addressing the “Medicine Cabinet” Syndrome
- January 02, 2013
- LEGAL ALERTS/ARTICLES
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The Prosecution of Gary D. Osborn—An Old School “Park” Prosecution?
- January 02, 2013
- LEGAL ALERTS/ARTICLES
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Are Food Allergen Thresholds on the (Far) Horizon?
- December 28, 2012
- LEGAL ALERTS/ARTICLES
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Your Dog as a Medical Device?
- December 27, 2012
- LEGAL ALERTS/ARTICLES
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DEA Proposes Controlling Lorcaserin in Schedule IV
- December 26, 2012
- LEGAL ALERTS/ARTICLES
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When is Yogurt Not Yogurt? Judge Lets FDA Decide
- December 26, 2012
- LEGAL ALERTS/ARTICLES
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Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance
- December 21, 2012
- LEGAL ALERTS/ARTICLES
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FDA Releases Draft Guidance on Enrichment Strategies for Clinical Trials
- December 20, 2012
- LEGAL ALERTS/ARTICLES
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In a Milestone for Regulation of Imported Foods, New Zealand and U.S. Food Safety Systems are Deemed Comparable
- December 19, 2012
- LEGAL ALERTS/ARTICLES
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“No-AG” Agreements are Not “Reverse Payments” Subject to Antitrust Scrutiny Says District Court in LAMICTAL Litigation
- December 18, 2012
- LEGAL ALERTS/ARTICLES
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Support Appears to be Growing to Delay the Medical Device Tax
- December 17, 2012
- LEGAL ALERTS/ARTICLES
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A Deep Dive Into the Second Circuit’s Caronia Decision, Potential Next Steps, and Potential Enforcement Fallout
- December 14, 2012
- LEGAL ALERTS/ARTICLES
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“Carcinogen-Free” Label Program Proposed in House Bill
- December 14, 2012
- LEGAL ALERTS/ARTICLES
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More Legislation Introduced to Strengthen State Cooperation and Federal Oversight of Compounding Pharmacies
- December 13, 2012
- LEGAL ALERTS/ARTICLES
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In Litigation, FDA Explains and Defends FSMA Efforts
- December 12, 2012
- LEGAL ALERTS/ARTICLES
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Proposed Legislation Seeks to Amend Controlled Substances Act’s Preemption Provision: A Reminder Of States’ Role in Regulating Drugs of Abuse
- December 10, 2012
- LEGAL ALERTS/ARTICLES
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Actelion’s Preemptive Strike over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company into the Mix
- December 07, 2012
- LEGAL ALERTS/ARTICLES
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Red Flags Rule Comes Back
- December 07, 2012
- LEGAL ALERTS/ARTICLES
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CDRH Issues Report on Improvements in Device Review
- December 06, 2012
- LEGAL ALERTS/ARTICLES
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In Landmark Ruling, Court Reverses Conviction Involving Off-Label Promotion
- December 06, 2012
- LEGAL ALERTS/ARTICLES
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ASBM Says Distinct USAN Names for Biosimilars are Needed
- December 04, 2012
- LEGAL ALERTS/ARTICLES
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Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of “Old” Opana® ER and With Respect to Approved and Pending ANDAs
- December 04, 2012
- LEGAL ALERTS/ARTICLES
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In a FSMA First, FDA Suspends a Food Facility’s Registration
- November 30, 2012
- LEGAL ALERTS/ARTICLES
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Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing Conduct
- November 29, 2012
- LEGAL ALERTS/ARTICLES
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Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent
- November 28, 2012
- LEGAL ALERTS/ARTICLES
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No Preemption of California Class Action Targeting Nutrient Content Claims
- November 26, 2012
- LEGAL ALERTS/ARTICLES
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“Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus Brief
- November 26, 2012
- LEGAL ALERTS/ARTICLES
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FDA Seeks Comments on Custom Devices
- November 23, 2012
- LEGAL ALERTS/ARTICLES
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FDA Amends UDI Proposed Rule to Comply with FDASIA Requirements
- November 21, 2012
- LEGAL ALERTS/ARTICLES