Clinical Research Solutions
FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program
On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...
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
House Committee Releases Draft Discussion Bill Regarding FDA's Regulations of In Vitro Clinical Testing
On Tuesday, November 17, 2015, the House of Representatives’ Energy & Commerce Committee will hold a hearing entitled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The...
Clinical Research Solutions
FDA Provides Recommendations on Injectable Drug Dose Labeling
On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...
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...