Hyman, Phelps & McNamara P.C. presents a webinar on FDA Appeals - Improving Your Odds of Success; Trends, Expectations, Strategies March 21, 2012   12:30 - 2:00 p.m. ET

U.S. News & World Report Ranks HP&M as Top Tier FDA Law Firm - 2nd Year in a Row!

Recent FDA Law Blog Entries from www.fdalawblog.net

“Breathable Food” Comes Under Scrutiny

Seeking a Second Bite at the Apple? Lannett Petitions FDA on the “Grandfather” Status of Morphine Sulfate

FDA Wraps Up Responses to 2003 & 2004 Petitions on “Biosimilars”; Denies Outstanding Requests

BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill (Our 1,500th Post!)

Articles and Presentations

Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center  January 2012

CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment Interests  December 22, 2011

Court Ruling Casts Doubt On FDA's Use Of Guidance Documents  December 16, 2011

HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent  December 2011

Death, Taxes and DEA Inspections: Dealing with the Inevitable  November/December 2011

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