October 1, 2013Will the FDA provide more guidance or manage the process to share risk evaluation and mitigation startaegies (REMS)?By Brian , What the FDA will do to proactively manage the process to share Risk Evaluation and Mitigation Strategies (REMS) is ahot button topic that many in the pharmaceutical and biotechnology industry have been wondering, particularly as theFDA looks to …

September 1, 2013Navigating Recent Off Label Promotion DevelopmentsBy Brian , The Federal Food, Drug, and Cosmetic Act (FD&C Act)1 provides the US Food and Drug Administration (FDA) with regulatory authority over the manufacture and distribution of drugs.2 From the FD&C Act, the FDA has derived its authority to prohibit promotion of drugs for unapproved or off label 3…

January 31, 2013The Drug/Biologics Approval Process An FDLI PrimerBy Brian and Scot Pittman, This publication will explain, in practical terms, the approval processes for drugs and biologics. It will describe the various FDA premarket requirements and …

December, 2012Understanding and Incentivizing BiosimilarsBy Jason Kanter and Robin Feldman, Congress recently passed the Biosimilars Act in an attempt to replicate the success that generic small molecule drugs have enjoyed under the Hatch Waxman Act. The Biosimilars Act provides a pathway for biosimilars to achieve quicker and less expensive FDA approval than what is required for a …

December 3, 2012Challenges to the Development of a Biosimilars Industry in the United StatesBy Brian , On March 23, 2010, President Obama signed the Biologics Price Competition and Innovation Act of 2009 («the Biosimilars Act») into law.1 The Biosimilars Act is the first piece of legislation that explicitly provides a pathway for the approval of …

August 1, 2011Revisiting the Debate on an Orange Book for the Biologics Price Competition and Innovation ActBy Andrew S. Wasson, President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law more than a year ago, yet industry stakeholders, lawyers and academic commentators continue to…

February 23,2011Should FDA Undertake More Than a «Ministerial» Role With Respect to Patent Information?By Brian J. Malkin and Andrew S. Wasson, The U.S. Food and Drug Administration (FDA) has taken the position that it will not substantively review patents for compliance with the Federal Food, Drug and Cosmetic Act (FDCA), as amended by…

February 1, 2011 Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009By Brian J. Malkin and Andrew S. Wasson, The industry and media have devoted an increasing ammount of attention to a class of biological products referred to as «biobetters» which are cast as…

June 1, 2010Biosimilars are a Reality Key Features of the Biologics Price Competition and Innovation Act by Brian J. Malkin and Andrew S. Wasson, After years of debate and several…

April 1, 2010New FDA Pathway for Biosimilars Complex Approval and Litigation Scheme by Brian J. Malkin, On September 17, On March 23, 2010, President Obama signed…

August 1, 2009The Letter of the Law. How FDA regulation will impact your business by Brian J. Malkin, Commentators from all sides of the tobacco debate have shared…

April 1, 1999FDA’s Role in Admiinistering PTEby Brian J. Malkin, The Food and Drug Administration (FDA) works extensively with…

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