Clinical Research Solutions

Quality Agreements and the Pharmaceutical Supply Chain

Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...

Clinical Research Solutions

FDA Clarifies its Definition of “Convenience Kit”

On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...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

Obtaining IND-Related Feedback from FDA

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to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...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’s Enforcement of Section 503B of the Federal Food, Drug, and Cosmetic Act

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

Formal Meetings with the FDA Regarding Biosimilars: What’s Changed?

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

There’s an App for That: FDA Launches Orange Book Express App

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

Draft Guidance for Microbial Vectors Used for Gene Therapy Outlines FDA Safety Concerns

Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...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 Investigates Risk of Off-Label Tramadol Use in Children

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

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

Drug Development Questions And The FDA - The End Of The Black Hole

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...

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