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the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...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
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
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,...
Clinical Research Solutions
For most drugs, the process of developing and obtaining FDA approval of a generic version is simple and well-defined: sponsors must only prove that their product is pharmaceutically equivalent and...
Clinical Research Solutions
When the OTC drug review was undertaken in the 1970s, it was deemed the best solution available at the time for efficiently assessing the safety and efficacy of the countless drug products being sold...
Clinical Research Solutions
One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases,...
Clinical Research Solutions
In the new guidance on substances that can be added to foods, including beverages and dietary supplements, the FDA reminds manufacturers that the excipients added to oral dosage forms of these...