Clinical Research Solutions
FDA Guidance: Design & Analysis of Shedding Studies During Preclinical & Clinical Development
Recently, FDA published a guidance (entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products”) providing sponsors with recommendations on how...
Clinical Research Solutions
Learn Your Lessons Well: How Regulatory Strategies and Clinical Trial Design Affect Approvability
A recent analysis by the Tufts Center for the Study of Drug Development places the price tag of bringing a new drug to market at around $2.6 billion. The reason for this is simple: failure. Drugs...
Clinical Research Solutions
Why Are My Swab Recoveries So Low?
Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...
Clinical Research Solutions
FDA Updates Informed Consent Guidance
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...
Quality & Compliance
Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process
Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...
Quality & Compliance
Formulation and Process Development: Gate 6 of the Nine Gate Transfer Process for Moving Production
Today, we are continuing our blog series on the Nine Gate Transfer Process for Moving Production from Site to Site, with Gate 6: Formulation and Process Development. If you have missed any previous...
Clinical Research Solutions
FDA Revisits the Topic of INDs for Dietary Supplements
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,...
Quality & Compliance
The Transfer Process Map: Gate Four in the Nine Gate Transfer Process for Moving Production
If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...
Quality & Compliance
The Transfer Plan: Gate Three in the Nine Gate Transfer Process
Today I would like to present the third entry in the series discussing the Nine Gate Transfer Process for moving production from site to site: the Gate 3 Transfer Plan. In case you missed them, you...
Quality & Compliance
The Nine Gate Transfer Process for Moving Production from Site to Site: Gate 1
Pharmaceutical news today featured another article about a manufacturing plant closure and the layoff of a thousand employees. Demand for pharmaceutical products continues to grow and will continue...