Search Results for:
Hyman Phelps Mcnamara Pc
(762)
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ARTICLES(762)
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On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
- March 02, 2012
- LEGAL ALERTS/ARTICLES
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FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates
- March 01, 2012
- LEGAL ALERTS/ARTICLES
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FDA Denies Washington Legal Foundation Citizen Petition
- February 28, 2012
- LEGAL ALERTS/ARTICLES
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“Breathable Food” Comes Under Scrutiny
- February 24, 2012
- LEGAL ALERTS/ARTICLES
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Seeking a Second Bite at the Apple? Lannett Petitions FDA on the “Grandfather” Status of Morphine Sulfate
- February 21, 2012
- LEGAL ALERTS/ARTICLES
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FDA Wraps Up Responses to 2003 & 2004 Petitions on “Biosimilars”; Denies Outstanding Requests
- February 17, 2012
- LEGAL ALERTS/ARTICLES
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BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill
- February 16, 2012
- LEGAL ALERTS/ARTICLES
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Full Circle: Rush Bill Would Make Most Patent Settlement Agreements Unlawful
- February 15, 2012
- LEGAL ALERTS/ARTICLES
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MDR Reporting - FDA Appears to Disavow The Two Year Presumption
- February 15, 2012
- LEGAL ALERTS/ARTICLES
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Quality Encompasses Safety (At Least If You’re an Almond)
- February 14, 2012
- LEGAL ALERTS/ARTICLES
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Reps. Rogers and Markey Introduce Bill to Implement Withdrawn Pediatric Medical Device Rule
- February 13, 2012
- LEGAL ALERTS/ARTICLES
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The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)
- February 13, 2012
- LEGAL ALERTS/ARTICLES
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“Soon” Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft Guidances
- February 13, 2012
- LEGAL ALERTS/ARTICLES
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DC District Court Grants FDA Summary Judgment in Generic LOVENOX Dispute
- February 10, 2012
- LEGAL ALERTS/ARTICLES
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A Solution in Search of a Problem: Safety of Untested and New Devices Act of 2012
- February 07, 2012
- LEGAL ALERTS/ARTICLES
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Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage
- February 07, 2012
- LEGAL ALERTS/ARTICLES
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GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation
- February 07, 2012
- LEGAL ALERTS/ARTICLES
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Senators Casey and McCain Introduce Bill to Streamline De Novo Process and Reclassify Preamendment Devices
- February 07, 2012
- LEGAL ALERTS/ARTICLES
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CDRH Issues its Strategic Priorities for 2012
- January 31, 2012
- LEGAL ALERTS/ARTICLES
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PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds
- January 31, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court Rules Federal Meat Inspection Act Preempts California's Ban on Slaughter of Non-Ambulatory Animals
- January 30, 2012
- LEGAL ALERTS/ARTICLES
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A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added Twist
- January 26, 2012
- LEGAL ALERTS/ARTICLES
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GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and Misuse
- January 26, 2012
- LEGAL ALERTS/ARTICLES
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Leap Year and Hatch-Waxman -- An Unusual Conundrum Years in the Making
- January 25, 2012
- LEGAL ALERTS/ARTICLES
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Congressional Representatives Press FDA For Action on Third-Party Audits
- January 23, 2012
- LEGAL ALERTS/ARTICLES
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FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique Provisions
- January 20, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court To Decide When EPA and Perhaps Other Federal Agencies Can be Sued in Federal Court
- January 18, 2012
- LEGAL ALERTS/ARTICLES
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National Organic Program Proposes to Change Listing of Nutrients That Can be Added to Organic Food
- January 17, 2012
- LEGAL ALERTS/ARTICLES
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FDA Denies Petition Seeking to Add Application Information to Drug Labels
- January 16, 2012
- LEGAL ALERTS/ARTICLES