FDA makes changes to dispute resolution guidance

FDA has updated its guidance on resolving disagreements and disputes between sponsors and the agency. The goal is to avoid messy disputes by holding discussions that will hopefully lead to more timely resolutions. The revisions of the guidance state more appropriate regulatory actions for a formal dispute resolution request (FDRR). To get less people involved, the sponsor must first interact with the deciding official before appealing to higher up management. To read Zachary Brennan’s full article on raps.org, click here.

Pearl Pathways hires Mary Anne Gfell


Clinical research professional and former Covance Global Project Manager, Mary Anne Gfell, joins Pearl Pathways.

Bringing over 15 years of experience in clinical research and quality compliance, Gfell is a key addition to the Pearl Pathways team. Prior to joining Pearl Pathways, she worked as a Global Project Manager at Covance, a multi-national CRO where she managed central laboratory services for Phase 1 through 4 clinical global studies. Gfell has extensive expertise in both drug and device trials, and started her career in a clinical setting as a Med Tech. She has further expertise in the creation and oversight of quality systems as well as the development of clinical protocols.

Gfell is an active Certified Clinical Research Coordinator (CCRC), a member of the Association for Clinical Research Professionals (ACRP), and holds her project management certification.

To read full press release, click here.

FDA and industry groups working to bring patient perspective into the regulatory process

Alexander Gaffney of RAPS.org posted an interesting article regarding FDA’s new Patient-Focused Drug Development Initiative, created to obtain patients’ perspectives on the severity of their conditions and the treatment options currently available. The goal is to increase patient involvement in the regulatory process.

FDA isn’t alone with this idea. In addition to PhRMA’s patient initiative that launched in November 2013, the advocacy group FasterCures is forming a Benefit Risk Advisory Council. Council members come from a variety of backgrounds including industry, patient and trade groups, rare disease advocates, academic institutions, and government. FasterCures’ intention with this group is provide feedback from stakeholders to drug developers and regulators.

To read the full article, click here.

Heidi Strunk to present at IMDMC Regulatory 101 on August 19th

We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. Session two will cover the post-market requirements and compliments the discussion of pre-market requirements back in May. Your attendance is encouraged, even if you were unable to join us for session one. Regulatory 101 is a popular event designed for staff who are new to the FDA regulatory world or those who just need a refresher.

Pearl Pathways’ own Heidi Strunk will be presenting an overview of post-market regulatory requirements at 9:00am; we hope to see you there!


What: IMDMC 2014 FDA Regulatory 101 Course, Part 2.

When: August 19th from 8:00am – 5:00pm

Where: Montage Banquet Hall in Indianapolis, Indiana


To register for the event, click here.

Pearl Pathways Hires Heidi Hancock Strunk

Pearl Pathways is pleased to announce the recent hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. Strunk brings over twenty-three years of experience in FDA-regulated industries and thirteen years in management, including extensive expertise in the medical device and and in vitro diagnostic (IVD) industries. To read the full press release, click here.

Closing the gap in the US drug import system

Alexander Gaffney of raps.org posted an interesting article regarding the current standing of the drug import system. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may prohibit the import of any drug that has not been approved in the United States. Consequently, FDA is often required to either deny the product or detain it for further processing. This requirement presents a loophole to exporters: in the event that their product has been refused by FDA, its sponsor may request to have the drug returned (even misbranded or counterfeit drugs) and essentially gain the opportunity to resend it with a greater chance of passing inspection.

FDA’s major concern regarding these imports is the negative impact on consumer health because of misbranded dietary supplements and counterfeit drugs. In fact, FDA estimates that anywhere between 20 and 100 million packages containing drugs are imported into the U.S. each year, many from questionable online pharmaceutical sources.

In an effort to solve this issue of imported drugs, a proposition has been created granting FDA authority to destroy any refused drug without providing its sponsor an opportunity for return as long as the value of the drug is less than $2,500. In this case, the owner of the drug would then receive a notice of intent to destroy from FDA.

To read the full article, click here.

Bowker to present at IMDMC Regulatory 101 course – May 15, 2014

Plan on joining us at the Indiana Medical Device Manufacturers Council (IMDMC) event entitled “Regulatory 101” on May 15, 2014.  Gretchen Bowker, COO of Pearl Pathways will be speaking at the event at the Montage Banquet Hall in Indianapolis, Indiana. This is a full day event and is appropriate for staff who are relatively new to the FDA regulatory world or those who need a FDA refresher. Gretchen will be presenting at 1:30 on Clinical Trials and IDE’s. To register for the event click here and to visit the IMDMC website, see this link.

FDA finalized new pediatric information rule

FDA released a final rule in January 2014 regarding required pediatric information that must be included in medical device PMA, HDE, and PDP submissions in order for the devices to be approved.   To review the Final Rule entitled “Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure“ on the Federal Register, click here.  This rule became active on April 10, 2014. Alexander Gaffney from raps.org  shared in his article that the draft of this rule was created in February. The reason for the rule is common sense shares Gaffney.  “Products that are likely to be used by children should be able to be used safely by them. Safe use provisions require data. Therefore, companies should obtain data.”   This is not unprecedented as the industry’s drug counterparts have been having to do this for a while The final rule says that companies will need to include any descriptions of pediatric populations that suffer from the disease that the device is intended to treat, prevent, diagnose, and cure. To read the full article click here.

Diabetes Testing Devices-FDA Releases New Guidance Documents

Alexander Gaffney of raps.org details the Food and Drug Administration’s (FDA) push for new development approaches for diabetes testing systems.  FDA has typically not distinguished between prescription and non-prescription diabetes testing devices.  In review of the guidance documents, it is clear that FDA wishes to address concerns regarding the potential sharing of devices, as well as cleanliness. To view Gaffney’s article, click here.  To help address these concerns, FDA released two new separate draft guidances on January 6, 2014.  To see both guidance documents, see the links below:



All comments are due April 6, 2014.  Need help with your diabetes testing device or diagnostic, contact us at contact@pearlpathways.com.

Pearl Pathways’ website gets an update

Pearl Pathways’ website has recently seen a few upgrades in content. The News & Events section now provides a easy to read layout, two new pharmaceutical and one new medical device Case Studies have been added, and several of the Services pages have been updated to include more detailed descriptions of the breadth of our service offerings. Check out the changes at pearlpathways.com.