Should Oral Contraceptives Be Available Over the Counter?

Posted on March 2014 by Britt Wahlin, AM, Director of Development and Communications, Ibis Reproductive Health Kate Grindlay, MSc, Senior Project Manager, Ibis Reproductive Health and Daniel Grossman, MD, Vice President of Research, Ibis Reproductive Health

Policy Forum – Oral Contraceptives to Over-the-Counter Status This issue of Policy Forum (Volume 4, Number 3, March 12, 2014) – Should Oral Contraceptives Be Available Over the Counter?...read more

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

What Are the Key Implementation Challenges in the Supply Chain Security Provisions of the Drug Quality and Security Act?

Posted on December 2013 by Vince Ventimiglia, Counsel, Health and Life Sciences Group, Faegre Baker Daniels and Eric Marshall, Associate, Health and Life Sciences Group, Faegre Baker Daniels

In this Policy Forum, Ventimiglia and Marshall provide a comprehensive overview of the drug supply chain security provisions of the Drug Quality and Security Act (DQSA) and explore three areas of i...read more

In this Policy Forum, Palmer discusses policy questions raised by the “Compounding Quality Act” or Title I of the recently enacted Drug Quality and Security Act (DQSA).  Specifical...read more

How Should FDA and Generic Drug Manufacturers’ Respond to FDA’s Proposed Changes to Generic Drug Labeling Rules?

Posted on November 2013 by Jane Bockus, Shareholder, Cox Smith and Francisco T. Rivas, Vice President, Compliance & Integrity Programs, NSF—Becker Consulting

In this Policy Forum, Bockus and Rivas explore the impact for generic manufacturers and for FDA of the proposed changes to FDA’s generic drug labeling rules.  The authors state that this...read more

In this Policy Forum, Beakes-Read and Meyer focus on the increasingly lengthy controlled-substance-scheduling process for new molecular entities (NMEs).  The authors explain that the growing g...read more

In this Policy Forum, the authors present a set of Core Principles as policy recommendations developed through a series of dialogues convened by the Institute for Environmental Negotiation at the U...read more

Can FDA Accelerate Clinical Trial Timelines and Completion Using Documented cGMP Processes?

Posted on October 2013 by Anton Lewis Usala, M.D., President and CEO CTMG, Inc. and Neil P. Di Spirito, Esq., Special Counsel, Rumberger, Kirk & Caldwell, P.A.

In this Policy Forum, Usala and Di Spirito argue that not requiring quality control systems in regulating clinical trials has led to submission of contradictory data to FDA, increased drug developm...read more

Should FDA Establish Criteria for the Approval to Commercially Market Radioactive Tracers for Biomarker Applications?

Posted on September 2013 by Dennis P. Swanson, R.Ph., M.S. Professor, School of Pharmacy University of Pittsburgh

In this Policy Forum, Swanson argues that increasing the use of radioactive tracers for biomarker applications to accelerate the development of traditional, therapeutic drug products or as diagnost...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