Search Results for:
Hyman Phelps Mcnamara Pc
(762)
- Page 16
ARTICLES(762)
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FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and “Trust Me” Approach to Exclusivity Decisions
- October 05, 2012
- LEGAL ALERTS/ARTICLES
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HHS OIG Reports Take Aim At Weight Loss and Immune Support Dietary Supplements
- October 04, 2012
- LEGAL ALERTS/ARTICLES
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New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations
- October 04, 2012
- LEGAL ALERTS/ARTICLES
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What’s the Hang-up? Apotex Sues FDA over Compliance Failure That’s Stalling ANDA Approvals
- October 04, 2012
- LEGAL ALERTS/ARTICLES
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GAO Report on Potential Information Security Risks for Certain Devices
- October 03, 2012
- LEGAL ALERTS/ARTICLES
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FDA’s Voluntary ISO Audit Submission Program
- October 02, 2012
- LEGAL ALERTS/ARTICLES
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Another Orphan Drug Battle; Depomed Sues FDA over GRALISE Orphan Drug Exclusivity
- September 28, 2012
- LEGAL ALERTS/ARTICLES
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In Search Of (ISO) Court in Which to Challenge DEA ISO? The D.C. Circuit May Have an Answer for You
- September 28, 2012
- LEGAL ALERTS/ARTICLES
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D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages
- September 27, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Draft Compliance Guide on Pet Food Intended to Diagnose, Cure, Mitigate, Treat or Prevent Disease, Including Obesity
- September 27, 2012
- LEGAL ALERTS/ARTICLES
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Insight into FDA’s Implementation of FDASIA for Devices
- September 27, 2012
- LEGAL ALERTS/ARTICLES
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Is it a Drug or Device? Court Requires FDA to Explain Itself
- September 27, 2012
- LEGAL ALERTS/ARTICLES
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Suit Targeting Benecol Dismissed on Preemption Grounds
- September 27, 2012
- LEGAL ALERTS/ARTICLES
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Legislative Fix Would Allow FDA to Collect GDUFA User Fees
- September 21, 2012
- LEGAL ALERTS/ARTICLES
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The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted
- September 21, 2012
- LEGAL ALERTS/ARTICLES
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Patent Settlement Agreements: The Next Barrage
- September 19, 2012
- LEGAL ALERTS/ARTICLES
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In Florida, Watch How You Use “Honey”
- September 18, 2012
- LEGAL ALERTS/ARTICLES
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CDRH Seeks to Enhance Postmarket Surveillance Systems
- September 17, 2012
- LEGAL ALERTS/ARTICLES
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FTC Settlement with Medifast: Weight Loss and Maintenance Claims Must be Supported by One (Not Two) Well-controlled Study
- September 17, 2012
- LEGAL ALERTS/ARTICLES
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Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
- September 17, 2012
- LEGAL ALERTS/ARTICLES
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The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire
- September 14, 2012
- LEGAL ALERTS/ARTICLES
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If You are A Mobile App Developer, Get it Right from the Start, Please!
- September 11, 2012
- LEGAL ALERTS/ARTICLES
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KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
- September 10, 2012
- LEGAL ALERTS/ARTICLES
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The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies
- September 10, 2012
- LEGAL ALERTS/ARTICLES
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FDA and OMB Sued Over Delays in FSMA Implementation
- September 04, 2012
- LEGAL ALERTS/ARTICLES
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Hot Ticket Item - Patent Settlement Agreement Challenges
- September 04, 2012
- LEGAL ALERTS/ARTICLES
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IOM Issues Report on “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network”
- August 30, 2012
- LEGAL ALERTS/ARTICLES
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The Rabbit Hole Runs Deep; CDRH “Whistleblower” Scandal Involves a Once-Secret qui tam Lawsuit
- August 28, 2012
- LEGAL ALERTS/ARTICLES
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The POM Wonderful Case Enters the Playoffs
- August 27, 2012
- LEGAL ALERTS/ARTICLES
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Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
- August 22, 2012
- LEGAL ALERTS/ARTICLES