Clinical Research Solutions
FDA’s Expedited Programs Explained
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Four Benefits of Requesting an FDA Pre-IND Meeting
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
Clinical Research Solutions
FDA Meetings: How to Prepare for FDA Type B Meetings
The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...
Clinical Research Solutions
#3: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Clinical Research Solutions
Will There Ever Be An FDA-Approved Generic Insulin?
On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...
Clinical Research Solutions
FDA Thinking on Biosimilar Immunogenicity Issues - A Case Study Based on the Enoxaparin ANDA Approval
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...