Clinical Research Solutions
#7: Quality Systems Approach to Pharmaceutical CGMP Regulations
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
Clinical Research Solutions
#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...
Clinical Research Solutions
FDA Addresses Extrapolating Adult Data for Pediatric Use
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
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...
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,...