cGMP clinical grade stem cells’s Melissa Fassbender recently posted an article on a talk she had with James M. Anderson, M.D., Ph.D., Deputy Director, NIH Division of Program Coordination, Planning and Strategic Initiatives. This exchange reveals information on clinical grade stem line development that is hoped to help accelerate early-stage clinical research for diseases including Alzheimer’s, Parkinson’s, spinal cord injury, diabetes and muscular dystrophy.  Anderson talks about how clinical grade cells are developed under regulations and quality control measures that ensure quality and safety standards of the cells for potential clinical applications in humans.  Click here to read Fassbender’s article and contact us if you need help with your cell therapy regulatory filings or clinical trials.  Pearl has extensive experience with cell therapy products.

FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

CMO quality agreements highly recommended by FDA

Zachary Brennan of reports that the US FDA is recommending the usage of written quality agreements by pharma companies and CMOs. Although the FDA does not require such documents under cGMP (current good manufacturing practices) regulations; parties that have not complied with the recommendation have been issued warning letters.  By definition the FDA says a written quality agreement is a document outlining the responsibilities for the owners of the drug and the CMO in terms of the basic cGMP regulations. Most of these documents follow a standard form of:

  • Purpose
  • Terms (effective date and termination clause)
  • Dispute resolution
  • Responsibilities, including communication mechanisms and contacts
  • Change control and revisions

The FDA is also offering case studies for situations where a quality agreement does not exempt a CMO’s facility from cGMP requirements. Overall, The FDA is using written quality agreements to reduce the likelihood of misinterpretation and error from the manufacturing process. Read the full article here.

EC GMP modifications could impact CMOs

The European Commission Directorate-General for Health and Consumers issued three revisions last week that impact various aspects of drug quality and biologic active pharmaceutical ingredients. The modifications range from relatively minor such as changes in one word to more noteworthy changes that involve manufacturing contracts. To learn more about the changes, click here.

Interactive Map Shows Global Distribution of 2011 FDA cGMP Warning Letters

A map has been released to display the locations of all FDA cGMP (Current Good Manufacturing Practice) warning letters issued in fiscal 2011. It is evident that the FDA is continuing its crackdown on overseas manufacturing plants as warning letters increased by 40% from last year. Mexico and India accounted for one-third of the total number of warning letters issued. It is also worthy to note that for the first time since 2009, no facility in South America received a warning letter. To read more, click here.

*image courtesy of Nick Taylor from

FDA Published Final cGMP Labeling Controls Rule March 20, 2012

Fifteen years ago the FDA set out to control cGMP labeling (Current Good Manufacturing Practice). The FDA first began its efforts to fix cGMP labeling in 1993 and eventually proposed a rule in 1997. The goal of its current final rule is to narrow the scope of its revisions made to cGMPs for cut and gang-printed labeling. It is believed that these two forms of labeling led to several drug recalls in the early 1990s. Another addition to the rule is to add a fourth control procedure which allows manufacturers to use any automated technique that physically prevents incorrect labeling. To read more about the FDA’s rule to control mislabeling, click here. To read more about this article, click here.