Looming deadline for manufacturers of antibacterial wash

Final ruling from the FDA was released on 9/6 that gives manufacturers of consumer antibacterial wash one year to remove 19 banned ingredients from their products.  The ingredients are not generally recognized as safe and effective and consumer antibacterial washes containing these will be considered misbranded effective 1 year after final rule publication in the Federal Register and cannot be sold.  Companies can submit for new drug applications which will be required for marketing, remove from the market or reformulate their products.  Read more in Zachary Brennan’s article on RAPS and in the Final Rule.

Need help in complying to this final rule?  Contact Pearl Pathways.

On October 3rd, Diana Caldwell moderating panel discussion at ACRP Circle City Chapter Fall Symposium

circlecity_blue-1There is still time to register today for the October 3rd ACRP Circle City Chapter 16th annual fall symposium at the Ritz Charles in Carmel, IN.  Pearl Pathways’ CEO and President Diana Caldwell will moderate a panel discussion of The Future of Research in Indiana.  There will be additional discussions on clinical research throughout the day and an excellent opportunity for networking with other research professionals.  For a look at the agenda and to register click here.  You can learn more about ACRP Circle City Chapter and the benefits of being an active member at this link.

Register now for September 21st webinar on Product Labeling by Brandwood Biomedical

brandwood logoOur partner, Brandwood Biomedical, is hosting a complimentary webinar Tearing down the Tower of Babel — Asia Pacific Product Labeling.  Join in the discussion on how regulatory affairs professionals deal with the many challenges of labeling requirements across the Asia Pacific and how to manage labeling across an international distribution chain.  Brandwood Biomedical CEO and Senior Consultant Grant Bennett will be leading the event next Wednesday, September 21st.  After the webinar, there will be opportunity for live Q&A.  Register here today.

UDI deadline extended for products with NHRIC and NDC codes

Unique Device Identifier (UDI) provision implementation is proving to be a large undertaking — a project involving many dependent tasks with multiple stakeholders including supply chain, pharmacies and payers.  “The UDI Rule, established in the Food and Drug Administration Amendments Act of 2007 (FDAAA), includes a provision that rescinds any NHRIC or NDC number assigned to a device.”  The extension to 2021 is being allowed to avoid possible disruption that could interfere with patient access to devices.  The extension was made based on feedback from industry — the guidance released on August 30th indicates that “FDA has revised the guidance to reflect the Agency’s intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.  We expect the UDI labeling requirements will be fully implemented by September 24, 2021.  We also believe additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems, which do not depend on having an NHRIC or NDC number on the device label.”  Zachary Brennan reports additional information on this topic in his informative article on RAPS.

Need help ensuring your company’s UDI compliance?  Contact Pearl Pathways to start the discussion of how we can help your team.

Save the date 9/23/16 – Indiana CTSI Annual Meeting

The 8th annual meeting of the Indiana Clinical and Translational Sciences Institute (CTSI) is being held on September 23rd.  At the event, Indiana CTSI is presenting the Watanabe Prize in Translational Research to Dr. Robert Lefkowitz, a Nobel Laureate in chemistry.  To learn more, click here.

When:    Friday, September 23rd

Time:     8am-3pmnew-ctsi-logo

Where:   Hine Hall on IUPUI Campus

Please register here to attend.

FDA is sending a message to 15 device manufacturers

FDANews reported in a recent article that 15 new warning letters were issued to device manufacturers for GMP violations.  One letter was issued to a U.S. company with the remaining 14 issued for foreign manufacturers.  The warning letters were issued after FDA investigators conducted inspections of the manufacturing facilities and found violations.  FDA states that manufacturers should correct violations promptly and failure to correct may result in legal action.

If you need help with device manufacturing challenges, Pearl Pathways can help you achieve quality compliance in your manufacturing.  Contact us and we can make a plan together.

Common Electronic Submissions Gateway (CEGS) targeted by years’ end

Striving for greater alignment in regulatory approaches, both FDA and Health Canada are continuing work to put in place the Common Electronic Submissions Gateway (CEGS) to allow industry to submit simultaneously to both regulators.  Full functionality is expected to be completed at the end of 2016.  CEGS is one initiative of the Canada-US Regulatory Cooperation Council (RCC).  RCC also has other Joint Action Plan Initiatives in developing common monographs for routine OTC drugs and teaming up to eliminate duplicate efforts on routine surveillance of GMP inspection reports.

“Increased collaboration between regulatory agencies in Canada and the U.S. will reduce unnecessary duplicative costs for manufacturers of pharmaceutical and therapeutic products, further streamline regulatory decision-making, and minimize the delays in bringing health and personal care products to the marketplace, thereby expanding consumer choice without compromising the safety, efficacy and quality of products,”  a joint action plan for the RCC says.

For more details and links, check out Zachary Brennan’s article in RAPS.

Pearl Pathways exhibiting at the RAPS Regulatory Convergence

raps regconvergence 2016Join us at the annual RAPS Regulatory Convergence in San Jose, CA from September 17-20.  Learn more about how to drive regulatory excellence and visit us at booth #111.  Some of the biggest challenges in the regulatory industry will be addressed in this year’s informative sessions.  Come together for great networking opportunities and the RAPS 40th anniversary.  To find out more information, visit the event homepage and register now.

RAPS publication features chapter authored by Pearl staff

gretchens bookWe are proud to announce that Gretchen Parker PhD, RAC, CIP contributed a chapter to a recent publication entitled “Global Medical Device Regulatory Strategy” published by the Regulatory Affairs Professionals Society (RAPS, purchase required). This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices.

Discussions cover medical device types, basic strategy components, and assembling a core development team from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction. There is information on device design and development elements, setting up a quality management system, labeling strategies, and manufacturing information. Other chapters look at the Notified Body’s viewpoint on regulatory strategy and that of regulators.  Additional information is included in the book, including the use of standards that cover global regulatory processes and how patents apply to medical devices.

Further information about this publication may be found on the RAPS website.  https://www.raps.org/ProductDetail.aspx?ProductId=96813130

Register now for a medical device Mock Recall Demonstration


Hosted by IMDMC and Stericycle on September 27th, the Mock Recall Demonstration is an excellent opportunity to learn and strategize to increase efficiency in a recall situation.  Attendees will team up to analyze and develop a recall strategy and more.  Follow this link for more information.  Register now!