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Hyman Phelps Mcnamara Pc (762)

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Hyman Phelps Mcnamara Pc (762)

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ARTICLES(762)

Picking a Proprietary Name for a New Drug is No Simple Task - FDA Issues a Draft Guidance on Best Practices in Developing Proprietary Names
June 05, 2014
LEGAL ALERTS/ARTICLES
Author: David Bryan Clissold, James C. Shehan
Law Firm: Hyman, Phelps & McNamara, P.C.

The Ascension of FDA’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide
June 05, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

Employers Beware: EEOC Appears to be Stepping Up Disability Discrimination Enforcement
June 03, 2014
LEGAL ALERTS/ARTICLES
Law Firm: Hyman, Phelps & McNamara, P.C.

WIRTW 323 (The "Why I hate Lawyers" Edition)
June 03, 2014
LEGAL ALERTS/ARTICLES
Law Firm: Hyman, Phelps & McNamara, P.C.

DOJ Announces Significant Policy Shift on Electronic Recordings of Statements; Will Other Agencies Follow?
June 02, 2014
LEGAL ALERTS/ARTICLES
Author: Anne K Walsh
Law Firm: Hyman, Phelps & McNamara, P.C.

U.S. District Court Agrees With PhRMA, Vacates HRSA 340B Orphan Drug Rule
June 02, 2014
LEGAL ALERTS/ARTICLES
Author: Joseph William Cormier, Alan Mark Kirschenbaum
Law Firm: Hyman, Phelps & McNamara, P.C., Hyman, Phelps & McNamara, P.C.

After Years of Waiting, FDA Finally Lets Rip With Prescription PEG 3350 ANDA Withdrawal Proposal
May 27, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA Scores an Initial Win in COPAXONE Litigation; When Will the Other Shoe Drop?
May 27, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA’s Proposal on Nutrition Labeling and Fiber
May 27, 2014
LEGAL ALERTS/ARTICLES
Law Firm: Hyman, Phelps & McNamara, P.C.

Mainers and FDC Act Preemption “In”, and PhRMA and Foreign Commerce Clause “Out” in Dispute Over Drug Importation Law
May 27, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

OIG Promises Scrutiny of Narrowly Focused Patient Assistance Programs Run By Independent Charities - Some Practices Previously Endorsed Are Now Suspect
May 27, 2014
LEGAL ALERTS/ARTICLES
Author: James C. Shehan
Law Firm: Hyman, Phelps & McNamara, P.C.

William Mitchell Law Review Celebrates 30 Years of the Hatch-Waxman Amendments
May 27, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

NOP Issues Final Guidance Concerning “Made with Organic” Claims
May 19, 2014
LEGAL ALERTS/ARTICLES
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA Issues Draft Guidance Regarding Food Allergen Labeling Exemption Petitions and Notifications
May 16, 2014
LEGAL ALERTS/ARTICLES
Author: Ricardo Carvajal
Law Firm: Hyman, Phelps & McNamara, P.C.

Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
May 16, 2014
LEGAL ALERTS/ARTICLES
Author: William T. Koustas, Jessica A. Ritsick
Law Firm: Hyman, Phelps & McNamara, P.C.

The Draft Guidance on Clinical Pharmacology Studies for Biosimilars - Is FDA Moving Forward, Sideways or Backwards by Retracing Steps Covered in the 2012 Draft Guidances?
May 16, 2014
LEGAL ALERTS/ARTICLES
Author: James C. Shehan
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA Issues Final Guidance for Providing Information on Pediatric Uses of Medical Devices
May 14, 2014
LEGAL ALERTS/ARTICLES
Author: Allyson B. Mullen
Law Firm: Hyman, Phelps & McNamara, P.C.

Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances
May 14, 2014
LEGAL ALERTS/ARTICLES
Author: Jeffrey Neal Wasserstein
Law Firm: Hyman, Phelps & McNamara, P.C.

Practitioner DEA Registration Numbers: Some Anomalies to Note
May 12, 2014
LEGAL ALERTS/ARTICLES
Author: Larry K Houck
Law Firm: Hyman, Phelps & McNamara, P.C.

Race to Market: Drugs vs. Dietary Supplements; FDA Plants a Landmine
May 12, 2014
LEGAL ALERTS/ARTICLES
Law Firm: Hyman, Phelps & McNamara, P.C.

Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition
May 12, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

Enough Is Enough! Citizen Petition Issues a Clarion Call to FDA to Remove Ranbaxy’s Roadblock to Generic Competition on Several Drugs
May 08, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst, Anne K Walsh
Law Firm: Hyman, Phelps & McNamara, P.C., Hyman, Phelps & McNamara, P.C.

Favorable Ruling for Companies Defending Off-Label Promotion Cases
May 07, 2014
LEGAL ALERTS/ARTICLES
Author: Anne K Walsh
Law Firm: Hyman, Phelps & McNamara, P.C.

Boning Up: FDA Revisits Pre-MMA 180-Day Exclusivity and Addresses a New Scenario
May 06, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA Denies Petitions Alleging Erroneous Triggering of NCE Exclusivity Start Date Before DEA Controlled Substance Scheduling Permitted Marketing; Litigation to Follow?
May 06, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

CDRH Announces Expedited Access PMA Program to Speed Development and Approval of Devices that Treat or Diagnose a Life-Threatening or Debilitating Disease and Meet an Unmet Medical Need
May 02, 2014
LEGAL ALERTS/ARTICLES
Author: Jamie K. Wolszon
Law Firm: Hyman, Phelps & McNamara, P.C.

FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty Acids
April 30, 2014
LEGAL ALERTS/ARTICLES
Author: Ricardo Carvajal
Law Firm: Hyman, Phelps & McNamara, P.C.

A Tough Stain to Beat: Decades After Taking Enforcement Action Alleging “Drug” Status, FDA Says Most Peroxide Tooth Whiteners are “Cosmetics” (for Now)
April 29, 2014
LEGAL ALERTS/ARTICLES
Author: Kurt Reid Karst
Law Firm: Hyman, Phelps & McNamara, P.C.

Deem the e-Cigarettes! Full Speed Ahead!
April 29, 2014
LEGAL ALERTS/ARTICLES
Author: David Bryan Clissold
Law Firm: Hyman, Phelps & McNamara, P.C.

The FDA Dietary Supplement Numbers Game
April 29, 2014
LEGAL ALERTS/ARTICLES
Author: Allan W Siegner
Law Firm: Hyman, Phelps & McNamara, P.C.

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