FLH Authors New FDLI Primer: The Drug / Biologics Approval Process


Frommer Lawrence & Haug LLP is proud to announce that the Food and Drug Law Institute (“FDLI”) just published the FDLI Primer, “The Drug/Biologics Approval Process” authored by FLH Partner Brian J. Malkin and Associate Scot Pittman. Mr. Malkin has been a member of the Primer Committee for several years now. Recently, FDLI decided to make each Primer separately available for purchase ($119 for nonmembers, $95 members) rather than an entire series for its predecessor FDLI Monograph publication. FDLI asked Mr. Malkin to author this Primer based on a previous FDLI publication authored by Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Regulatory and Policy, Pfizer, Inc. Updates in the FDLI Primer include adaptations based on recent FDA legislation, including the latest user fees acts for generic drugs and biosimilars and the Food and Drug Administration Safety and Innovation Act (“FSASIA”). According to FDLI, Primers are:

[E]xtensively researched, referenced, and edited by some of the most experienced and respected professionals in the field. … The Primers are designed to provide you with information and proprietary analysis to enable you to advise your clients or help your company comply with vexing issues, regulations, and guidance.

For this particular FDLI Primer, FDLI writes:

This publication will explain, in practical terms, the approval processes for drugs and biologics. It will describe the various FDA premarket requirements and pathways for drug and biologics application reviews, including changes enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA). Topics addressed will include the New Drug Application (NDA) process, non-NDA routes to market, generic drugs and the abbreviated new drug application process, as well as over-the-counter drugs and biologics. With this Primer, pharmaceutical stakeholders will feel confident that they have a helpful overview to support successfully navigating the FDA drug and biologics review processes.

Key topics covered in this FDLI Primer include:

  • What Is a “Drug”? What Is a “New Drug”
  • Preclinical Investigations
  • Clinical Investigations
  • The New Drug Application: Standards and Procedures
  • NDAs: FDA Action and Time Frames
  • The Postmarketing Period
  • Marketing Protections
  • Non-NDA Routes to Market: Historical Development
  • Generic Drugs and the Abbreviated New Drug Application Process
  • The New “Paper NDA”–Section 505(b)(2) NDAs
  • Over-the-Counter Drugs
  • Expedited Availability Mechanisms
  • Combination Drugs
  • Animal Drugs
  • Biologics
  • What Is a “Biologic”?
  • Biosimilars
  • Animal Biologics

Mr. Malkin and Mr. Pittman hope that the FDA bar finds this a valuable resource, particularly for new members or those wishing to gain an overview of the new legislative developments, and invite you visit FDLI’s website linked above for more information about this FDLI Primer.