Clinical Research Solutions
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Clinical Research Solutions
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
Clinical Research Solutions
FDA is investigating the use of tramadol, a narcotic-like pain reliever, in children aged 17 years and younger after learning of the “rare but serious” risk of slowed or difficult breathing....
Clinical Research Solutions
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
Commonly during drug development, significant issues arise for which FDA input is desired but that do not merit a full face-to-face multidisciplinary milestone meeting. In many cases, sponsors are...
Clinical Research Solutions
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...
Clinical Research Solutions
On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings...
Clinical Research Solutions
Medical device manufacturers may need to re-think their approach to demonstrating substantial equivalence (SE) in the 510(k) notification process, due to the FDA’s recent finalization of the guidance...
Clinical Research Solutions
We note with interest FDA’s recently released Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (April 2014). The guidance summarizes the...
Clinical Research Solutions
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,...