Newsletter | August 29, 2019

08.29.19 -- Expediting Regulatory Approval For Drug Development

Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness

In January 2019, the Food and Drug Administration (FDA) released two draft guidance documents regarding assessment of risk evaluation and mitigation strategies (REMS). These documents are meant to provide industry additional information to more accurately assess the effectiveness of their REMS. This article gives an overview of each of these documents and what they could mean for you.

505 (b)(2) vs. ANDA: How Complex Drugs Fit In

Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

Understanding The FDA’s Priority Review Voucher System

How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? This webinar reviews the hows and whys of the FDA’s Priority Review Voucher program.

Understanding NDAs

Marketing application submissions, including new drug applications (NDAs), biologics license applications (BLAs), and premarket approvals (PMAs) in the U.S., are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you navigate submissions in the most efficient and effective way.