Clinical Research Solutions
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
Clinical Research Solutions
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Clinical Research Solutions
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
Regulatory Sciences
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
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Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...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the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...