Pearl Pathways to expand into new market


Pearl Pathways is excited to announce its growth and expansion into a second location in College Station, Texas. The new office will be a part of The Garage, located within the Texas A&M Institute for Preclinical Studies (TIPS) building. The Garage is supported through the relationship of the Research Valley Partnership and its Research Valley Innovation Center in collaboration with Texas A&M University’s Office for the Vice President of Research.

President and CEO of Pearl Pathways, Diana Caldwell, commented “The Research Valley Partnership is promoting unique, world-class cGLP and cGMP infrastructure and capabilities in Bryan-College Station to support startup life science medical device and biopharma companies, which is a core client segment for Pearl,”

To read the full press release, click here.

FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.

To read Mehzer’s article, click here. Need assistance in managing your orphan drug designation or regulatory filing? Contact us.

CDRH increases foreign inspections as planned

The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013 to 2014. The increase in foreign inspections provides evidence that the center’s efforts have been working, according to Zachary Brennan, RAPS.

Currently, Chinese manufacturers are requiring more inspections, with Germany and Japan following suit. Although inspections increased abroad, the result of warning levels decreased. The chart below demonstrates the outcomes from domestic inspections compared to foreign inspections.

inspection outcomes

To read Brennan’s article on, click here.

IMDRF determines plan to balance global practices

According to Zachary Brennan, within the next four years, the International Medical Device Regulators Forum (IMDRF) will be focusing its efforts on pre-market review and post-market surveillance. IMDRF is made up of regulators from Australia, Brazil, Canada, China, EU, Japan, the US, and the World Health Organization. These efforts will help create a greater balance in regulatory practices across the globe.

Pre-market review initiatives have begun as regulators hold greater support in the reliability of data from other jurisdictions. IMDRF plans to improve post-market data sharing, establish a single audit program, and create an easier device tracking process.

For more information, visit Brennan’s article on

A guide to risk management



Our new eQMS service provider partner,, recently published a guide on risk management for medical device companies. The guide establishes seven stages that are essential to the risk management process: risk management planning, risk analysis, risk evaluation, risk controls, overall residual risk acceptability, risk management report, and production & post-production information. The guide also includes a list of keywords and definitions that must be understood in order to ensure successful risk management.

Creating a risk management process will allow medical device companies to identify hazards, estimate and evaluate risk, and develop, implement and monitor the effectiveness of risk control measure.

While all findings used to be recorded on paper, this can now be done technologically with the help of For more information, read the Definitive Guide to ISO 14971 Risk Management for Medical Devices, or visit’s website.

FDA to exempt genetic screening systems

FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be included in the exemption.

According to Zachary Brennan, “FDA may exempt a device if the agency determines that a 510(k) application is not necessary to provide reasonable assurance of the safety and effectiveness of a device.” Currently, the screening is only able to determine carriers of the genes, which have caused false positive results and unnecessary psychological distress.

FDA will make its final decision within the next 120 days. For the FDA report, click here. To find out more, visit the article.

Pearl Pathways partners with

gg_fullnamePearl Pathways is looking forward to a new partnership with, an eQMS service provider in Indianapolis, IN. This collaboration will provide clients a better way to navigate regulatory hurdles, shorten time to market, and reduce risk.

Diana Caldwell, President and CEO of Pearl Pathways, states that “Our dedication to driving improved value and efficiency in product development is one of our core values. Partnering with amplifies this position and further assists our customers in accelerating their regulatory pathway to success.”

To read the full press release, click here.

New case study from CDER

FDA Center for Drug Evaluation and Research (CDER) recently announced the release of a new case study, “Drug Approval: Bringing a New Drug to the Market,” to accompany their efforts of advancing the knowledge of drug regulatory processes within the industry. According to FDA, this case study uses real world scenarios within exercises and quizzes to promote learning and development. Its purpose is to educate on the subject of the drug approval process, and how to successfully navigate it.

For more information, click here.

Pearl Pathways to present at the ACRP symposium

Pearl Pathways will be presenting and exhibiting at the ACRP 15th annual fall symposium about excellence in research. The event will be held at the Sheraton Hotel in Indianapolis on November 6th, from 7:30AM-5:15PM. Pearl Pathways’ speakers include Gretchen Bowker, speaking on FDA audit tips, and Mary Anne Gfell and Patti Hunker, acting as panelists for the discussion, “FDA Form 483’s: The Truth of its Impact for Your Site,” and Diana Caldwell as moderator. To see event details, click here.

FDA aims to hold greater influence in global industry

Recently, Director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, addressed questions regarding the generic drug user fee act (GDUFA) and whether or not it will provide FDA the means to ensure quality. Woodcock stated that, while it’ll help fund globalization, currently it has limited impact. According to Nick Taylor’s article in In-Pharma, FDA has been attempting to oversee the global pharmaceutical supply chain. FDA is less interested in funding for increased resources, but more for powers to compliment the funds. They aim to bring to attention the problems with importing drugs in the US compared to other countries. Questions have risen regarding whether that would call for different domestic and overseas standards for manufacturers.

For a closer look, click here.