Search Results for:
Hyman Phelps Mcnamara Pc
(762)
- Page 13
ARTICLES(762)
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CSPI Petition Asserts that Sugar-Based Drinks are Unsafe and Requests that FDA Limit “Added Sugars” in Beverages
- February 20, 2013
- LEGAL ALERTS/ARTICLES
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OIG Report Calls Into Question Effectiveness of FDA’s REMS Program
- February 20, 2013
- LEGAL ALERTS/ARTICLES
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Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs
- February 18, 2013
- LEGAL ALERTS/ARTICLES
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First Fruits of FDASIA’s New Device Reclassification Procedure
- February 18, 2013
- LEGAL ALERTS/ARTICLES
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A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?
- February 13, 2013
- LEGAL ALERTS/ARTICLES
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FDA Denies Petition to Regulate Prescription Prenatal Vitamins Containing Folic Acid under an Rx Monograph
- February 13, 2013
- LEGAL ALERTS/ARTICLES
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Function Over Form or Form Over Function? Two Petitions Challenge FDA’s NCE Exclusivity Approach for Combination Drugs
- February 12, 2013
- LEGAL ALERTS/ARTICLES
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From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case
- February 07, 2013
- LEGAL ALERTS/ARTICLES
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Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress
- February 07, 2013
- LEGAL ALERTS/ARTICLES
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Reissue Patents and FDA’s Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?
- February 05, 2013
- LEGAL ALERTS/ARTICLES
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New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration
- February 04, 2013
- LEGAL ALERTS/ARTICLES
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FDA Advisory Committee Votes 19 to 10 In Favor of Rescheduling Combination Hydrocodone
- February 01, 2013
- LEGAL ALERTS/ARTICLES
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FDA Finalizes Guidance on Humanitarian Use Device Designations
- January 31, 2013
- LEGAL ALERTS/ARTICLES
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Government Does Not Seek Further Second Circuit Review in Caronia
- January 29, 2013
- LEGAL ALERTS/ARTICLES
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HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations
- January 29, 2013
- LEGAL ALERTS/ARTICLES
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Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability
- January 28, 2013
- LEGAL ALERTS/ARTICLES
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Biosimilar Substitution: Battles are Brewing at the State Level
- January 28, 2013
- LEGAL ALERTS/ARTICLES
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FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” Defined
- January 28, 2013
- LEGAL ALERTS/ARTICLES
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FTC Hammers POM Wonderful: Now On to the World Series
- January 18, 2013
- LEGAL ALERTS/ARTICLES
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DC District Court Sews Up Generic VANCOCIN Litigation; Decision Merely Refines and Adds New Details to Previous Preliminary Injunction Decision
- January 17, 2013
- LEGAL ALERTS/ARTICLES
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FDA Considering Alternative Approval Pathway
- January 17, 2013
- LEGAL ALERTS/ARTICLES
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FDA Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates
- January 17, 2013
- LEGAL ALERTS/ARTICLES
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Patient Power in Orphan Drugs
- January 15, 2013
- LEGAL ALERTS/ARTICLES
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New FDA Draft Guidance “Abuse-Deterrent Opioids—Evaluation and Labeling” to Permit Abuse-Deterrent Labeling Claims
- January 12, 2013
- LEGAL ALERTS/ARTICLES
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A Pre-MMA 180-Day Exclusivity Punt? What Gives?
- January 11, 2013
- LEGAL ALERTS/ARTICLES
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When is 5-Year NCE Exclusivity Less Than 5 Years?
- January 11, 2013
- LEGAL ALERTS/ARTICLES
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FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers
- January 09, 2013
- LEGAL ALERTS/ARTICLES
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On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules
- January 08, 2013
- LEGAL ALERTS/ARTICLES
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CDRH Releases Three Final Guidance Documents
- January 07, 2013
- LEGAL ALERTS/ARTICLES