Effective January 1st: China FDA Priority Review Procedure

The China Food and Drug Administration announced that manufacturers will be able to request priority review and approval of Class II (limited to imported application) and Class III (both domestic and imported application) devices exported to China beginning January 1, 2017. RAPS reported that the device must have been enrolled in the National Science and Technology Major Project or National Key Research and Development plan, or if it can diagnose and treat:

  • rare diseases, and has significant advantages in clinical practice
  • malignant tumors, and has significant advantages in clinical practice
  • specific and frequently occurring diseases in the elderly, and where there is no effective way to diagnose or cure such diseases
  • specific and frequently occurring pediatric diseases, and where there is no other effective treatment
  • or can address an urgent clinical need, and the same type of device has not yet been marketed in China

If you need help navigating the process for a priority review, please contact us. Pearl Pathways’ expert guidance can help you with your device applications and expedited approval if your device meets the CFDA’s fast-track approval requirements.

What’s your take on Outsourcing Pharma’s phrase “Chindia” for drug substance market?

Check out Melissa Fassbender’s intriguing article on API contract manufacturing trends to “Chindia” and perhaps back West again.  Have we come to understand API outsourcing to China and India as the new normal? 

According to Oursourcing Pharma‘s Fassbender, there are over 1,500 suppliers of API in China and 2,300 in India with an output of $27 billion. Dr. Enrico Polastro was quoted from his recent DCAT session entitles “Pharma fine chemicals outsourcing:  Back to the West?”

Check out the article here.  Need API supplier audits in China or India?  We can help with expert auditors on the ground in both countries.  Contact us to discuss your auditing needs. 

Pearl Pathways sponsors upcoming Indiana Life Sciences Collaboration Conference Series

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Pearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. It is an excellent forum that brings together key players in Indiana’s life science and healthcare arenas for intriguing business discussions on business strategy, solutions and development to promote growth.

Diana Caldwell, President and CEO of Pearl Pathways, shares that “The conferences add value for all of the major life science players in the state. It’s a great means to get us together, hear relevant topics from thought leaders, stay up to date, and network.”

Please joins us for the first conference of the year — The Continuing Disruption of Healthcare and Life Sciences Business Models for panel discussions on Changes in Healthcare and Medical Products “Space” and The Future of Medical Products in an Era of Reform: Implications of Value and Consumerism.

What:          The Continuing Disruption of Healthcare and Life Sciences Business Model

Where:       One America Tower, One American Square, Indianapolis

When:         February 19, 2016

A great way to start 2016, please click here to register, and put this important date on your calendar. You may learn more about the Indiana Life Sciences Collaboration Conference Series at this link.

Pearl Pathways participates in United Way’s Day of Caring program

As part of our community outreach activities, the staff at Pearl Pathways participated in a day of giving back through the Central Indiana United Way’s Day of Caring program on October 19th. We chose a facility close to our business neighborhood, and Pearl Pathways’ employees and family members spent time cleaning and preparing the dinner meal at the Mary Rigg Neighborhood Center in Indianapolis. We were able to interact with the children in the afterschool program as well as seniors next door. It was a great day filled with team building, fun, and giving back to the community. Check out photos from the event here.

About the Mary Rigg Neighborhood Center:

“Mary Rigg Neighborhood Center continues to be a place of help and hope for over 8,000 struggling individuals and families in southwest Indianapolis. An agency in “excellent” standing with United Way of Central Indiana, Mary Rigg Neighborhood Center has gained national recognition and funding for a number of programs including our efforts at George Washington Community High School and our employment training and money coaching programs.” To learn more, visit their website here.

Take this brief survey to hear your voice heard on preferred operating systems

In-Pharma is interested in finding out which mobile operating system is the most preferred among the drug industry between Andriod and iOS. Take this survey to help Gareth MacDonald conduct the necessary research.

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

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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.