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Should Congress Amend Sections 911 and 916 of the Family Smoking Prevention and Tobacco Control Act to Improve Postmarket Surveillance of Modified Risk Tobacco Products?

Posted on February 2012 by Sam F. Halabi

Written by Sam F. Halabi, Assistant Professor of Law at the University of Tulsa, this Forum discusses what the author identifies as shortcomings in the current regulations governing modified risk t...read more

Has the Government Ignored the Intent of Congress to Control Approved Medications According to their Abuse Potential?

Posted on February 2012 by John J. Coleman, PhD

by John J. Coleman, PhD This Policy Forum discusses the reasons for and problems associated with what he calls excessive and inexplicable delays in scheduling or rescheduling drugs. Using the 13-y...read more

Will FSMA Adequately Protect This Nation's Food Supply?

Posted on January 2012 by Randall K. Fields

by Randall K. Fields Under FSMA, the Food and Drug Administration (FDA) is required to establish a national food tracking system, in collaboration with state and local authorities, that mandates p...read more

Should the HHS Decision to Overrule FDA on Plan B Be Reversed?

Posted on January 2012 by Peter J. Pitts

by Peter J. Pitts This Policy Forum discusses the potential consequences of the Department of Health and Human Services’ (HHS) controversial decision to assert its authority over FDA. Pitts ...read more

How Can FDA Move Toward a Useful and Practical Preclearance System for Class II Devices?

Posted on December 2011 by William W. Vodra

Patent Use Codes, The Orange Book Section viii Statements: A Response to Terry Mahn's is it Time for FDA to Revise its Orange Book Rules to Deal with "Skinny-Labeled" Generic Drugs?

Posted on December 2011 by Frederick R. Ball, Elese Hanson

FDLI

Should Congress Amend Sections 911 and 916 of the Family Smoking Prevention and Tobacco Control Act to Improve Postmarket Surveillance of Modified Risk Tobacco Products?

Has the Government Ignored the Intent of Congress to Control Approved Medications According to their Abuse Potential?

Will FSMA Adequately Protect This Nation's Food Supply?

Should the HHS Decision to Overrule FDA on Plan B Be Reversed?

How Can FDA Move Toward a Useful and Practical Preclearance System for Class II Devices?

Patent Use Codes, The Orange Book Section viii Statements: A Response to Terry Mahn's is it Time for FDA to Revise its Orange Book Rules to Deal with "Skinny-Labeled" Generic Drugs?

Does the NDI Draft Guidance Significantly Impact the Safety of Dietary Supplements?

How Should FDA Use Naming and Labeling to Communicate Information About Biosimilars?

Should Congress Seek to Alter the Preemption Schism Established by Wyeth v. Levine and PLIVA v. Mensing?

Is it time for FDA to revise its Orange Book rules to deal with "skinny-labeled" generic drugs?

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