Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?

Posted on February 2014 by Daniel A. Kracov, Partner, Abraham Gitterman, Associate, and Arnold & Porter, LLP

This issue of Policy Forum (Volume 4, Number 2, February 26, 2014) – Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ Abo...read more

Do Pending State Biosimilar Substitution Bills Violate State Constitutional Law Principles of Non-Delegation and Incorporation by Reference?

Posted on September 2013 by Neal Parker Section Head, Legal, Biologics Strategic Development, AbbVie

In this Policy Forum, Parker explains that since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, several state legislatures have introduced and some have enacte...read more

Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?

Posted on August 2013 by Ralph Hall, Professor of Practice at the University of Minnesota Law School, Of Counsel at Faegre Baker Daniels and CEO of MR 3 Medical LLC

This issue of Policy Forum (Volume 3, Issue 14, August 29, 2013)—“Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?” by Ralph Hall (Professor of Pract...read more

“Is FDA Ready to Regulate the World’s First Biotech Food Animal?” (Volume 3, Issue 12, July 24, 2013) “Is Unaccountable Regulatory Delay and Political Interference Undermin...read more

The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator, or All of These?

Posted on June 2013 by Roseann B. Termini (Adjunct Professor) and Anthony Knabb diDonato (Juris Doctor Candidate, December 2013); Widener University School of Law

This issue of Policy Forum (Volume 3, Number 11, June 26, 2013) – The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator, or All of These? &ndash...read more

How Can the FDA Encourage Social Media Use by Pharmaceutical and Medical Device Companies?

Posted on June 2013 by Nicole D. Galli (Partner-in-Charge of Wilmington & Philadelphia offices), James A. Brown (Associate), Christopher J. Lalak (Associate); Benesch, Friedlander, Coplan & Aronoff LLP

This issue of Policy Forum (Volume 3, Number 10, June 12, 2013) – How Can the FDA Encourage Social Media Use by Pharmaceutical and Medical Device Companies? – describes the extent to wh...read more

In the Aftermath of Parens Patriae: Can Private Copycats Still Sue?

Posted on April 2013 by James M. Beck, Counsel, Reed Smith LLP

This issue of our Policy Forum (Volume 3, Number 8, April 24, 2013) — In the Aftermath of Parens Patriae: Can Private Copycats Still Sue? — explains that pharma...read more

This issue of Policy Forum (Volume 3, Number 6, March 27, 2013) – Biosimilar Naming: How Do Adverse Event Reporting Data Support the Need for Distinct Non-Proprietary Names for Biosimila...read more

Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health?

Posted on March 2013 by Fern P. O’Brian, Partner, and Barbara A. Lum, Associate, Thompson Hine, LLP

In this issue of our Policy Forum (Volume 3, Number 5, March 13, 2013) – Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health? – examines ...read more

This issue of Policy Forum (Volume 3, Number 4, February 27, 2013) explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine...read more