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February 3, 2016
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...
December 16, 2015
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...
October 27, 2015
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...
October 22, 2015
On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...
September 9, 2015
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...
March 26, 2015
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...
January 28, 2015
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...
August 21, 2014
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...
February 6, 2014
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,...