Reminder of eCTD Deadlines Approaching

A reminder that Electronic Common Technical Document (eCTD) deadlines are approaching. All submissions to the FDA including NDA, ANDA, BLA and DMFs are required to be submitted in eCTD format beginning on May 5, 2017.  IND submissions are required to be submitted in eCTD format beginning on May 5, 2018.  FDA informs that submissions that do not meet the specifications in the eCTD guidance will not be filed or received.  Paper will no longer be accepted after the dates noted.

Pearl Pathways has an experienced team to help with your regulatory submission authoring, publishing, and eCTD filings. Contact us for a value added partner to assure no interruption in your regulatory filings.

Let Pearl Pathways help with your biocompatibility concerns

Pearl Pathways invites you to look over a final guidance just released by the FDA Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”  This encourages medical device manufacturers to first start with a risk assessment to determine if new biocompatibility testing is required for premarket submissions.  It also explains new test-specific recommendations to follow.

The FDA is also holding a free webinar on July 21, 2016 discussing this final guidance. Click here for information on how you can dial-in to hear the presentation and also ask questions. Registration is not necessary.

Pearl Pathways’ experienced team is ready to assist your product development team with your biocompatibility evaluations. Contact us to be your partner in accelerating your product development regulatory pathways.

News on Compassionate Use

The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive.  In a statement released in early June from FDA Commissioner Robert Califf, M. D., the FDA released 3 guidance documents with information on Compassionate Use drugs and biologics.

The first guidance to note covers Individual Patient Expanded Access Applications – Form FDA 3926.  New Form 3926 is specifically for physicians to use to request access to investigational drugs for their patients who need these therapies to stay alive.  FDA also has instructions for completing the form.

There are 2 additional guidance documents to note that provide additional clarity on Compassionate Use. One of the guidance documents explains Compassionate Use using a Question and Answer format – click here to read.  The other guidance covers how a patient may be charged for these investigational drugs – click here to read.

Pearl Pathways’ and Pearl IRB’s experienced teams are ready to help you with this process. Expediting regulatory pathways is what we are about — contact us.

Update on OTC Drug User Fee program activity

FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff of 18 employees to manage.  The idea is that implementing a user fee program may result in great benefits and advances in over-the-counter drugs to help us manage symptoms and conditions safely without the oversight of a doctor.

Zachary Brennan, RAPS, posted an article that has additional informative links that follow the current FDA activity on this topic.  Brennan indicates that FDA is still seeking input/perspectives from stakeholders as they work toward a more defined approach.  Help them take a first “bite” into this huge project by commenting.

Sign up now for 2nd Annual Cell Therapy and Regenerative Medicine Symposium – June 13

Pearl Pathways is a proud supporter and sponsor of the 2nd Annual Cell Therapy and Regenerative Medicine Symposium to be held June 13, 2016 in Indianapolis, Indiana. The theme is commercialization and the title of this year’s program is “Commercialization and Health Care System Engagement in Regenerative Medicine: Disruptive Solutions for Unmet Medical Needs”

This two day event will include sessions on Day 1 and an opportunity to register for individual regulatory consultations on Day 2. Attendees are also invited to submit abstracts which will be presented at a poster session.

Gretchen Bowker, COO of Pearl Pathways will be attending and offering 1-1 consulting sessions with researchers on Day 2.

What: Commercialization and Health Care System Engagement in Regenerative Medicine: Disruptive Solutions for Unmet Medical Needs

Where: The Athenaeum 401 E. Michigan Street Indianapolis, IN 46202

When: June 13 – 14, 2016: See agenda for session times

Click here to register for the event.

Will we see you at the upcoming RAPS Indiana Chapter meeting, June 16th?

raps indianaThe RAPS Indiana Chapter, chaired by Pearl Pathways’ COO & RAC, FRAPS, Gretchen Bowker, is hosting an evening of networking and expert presentation by Susan Resnick, PhD of 3D Communications. The presentation is entitled, “Practices and Preferences of CDRH Advisory Committee Members – Know Your Audience”. The event is the evening of June 16th, 6:00pm – 8:30pm, at The Rathskellar Restaurant, Indianapolis, and is for promoting education and networking among local regulatory professionals. To get the latest understanding of practices and preferences of advisory committee members and how to prepare for panel meetings, don’t miss the presentation – click here for more details! Register today.  You can also register by calling +1 301 770 2920 ext. 200. We hope to see you at this special event!

Using Comparability Protocols for CMC postapproval changes

FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change. FDA defines a CP as a comprehensive plan for “assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” When assessing how a CMC change may affect product quality under a CP, be sure to have the following established for continuous improvement:

  • An understanding of the product and manufacturing process
  • A robust control strategy
  • Risk management activities over a product’s life cycle
  • An effective pharmaceutical quality system

 

For more information, read Dan Stanton’s article at in-PharmaTechnologist. Let Pearl Pathways help you with your CMC approach and regulatory submissions for both drug substance and drug product. Contact us here.

Pearl Pathways proud sponsor of Indiana Life Sciences Collaboration Conference Series at Cook Medical World Headquarters, May 13th

life sciencesPearl 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. This is an excellent forum bringing 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 May conference — The Shift from In-patient to Alternate Care Settings to listen to stakeholder perspectives on how companies, providers and payers are seeing and responding to technology advances, cost pressures, and patient visits and treatments moving out of traditional hospital settings.

What:          The Shift from In-patient to Alternate Care Settings

Where:       Cook Medical World Headquarters 750 Daniels Way, Bloomington, IN

When:         May 13, 2016

To join in the May conference, please register here. To find out more about the Indiana Life Sciences Collaboration Conference Series, see this link.

Deadline fast approaching for Class II medical device compliance with UDI

September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID (Global Unique Device Identifier Database). Device labeling documentation planning is key since once the DI is submitted for a device and entered into the GUDID; further, there are rules for editing during a grace period only and companies may find themselves in situations requiring them to have to obtain a new DI for a device. Keep watching for any FDA updates that may post as this deadline approaches.

More details can be found in Michael Mezher’s informative article posted on RAPS. Pearl Pathways has an experienced team ready to help with your UDI compliance planning and execution, contact us here.

Reflection on the IBJ Life Science Power Breakfast panel discussion

The Indianapolis Business Journal (IBJ) hosted the IBJ Life Science Power Breakfast Series this morning at the Marriott Hotel downtown Indianapolis.  It was a great panel discussion with industry leaders and well represented by many of the regional life sciences companies and service providers, including  (and proud sponsors) Pearl Pathways’ CEO Diana Caldwell and Director, Business Development Chad Pannucci.  In addition to an interesting presentation and panel discussion, we enjoyed conversation and getting better acquainted with some of our life science clients & colleagues from Indiana startups, universities and industry experts hosted at the Pearl Pathways table.  The impact of the Indiana life science industry cannot be overstated.  As mentioned, the output by Indiana life science companies (#medical device, #pharmaceutical, #biotech, #diagnostic etc) represents a $59B per year economic impact and almost $10B in worldwide annual exports where 1 out of every 10 Hoosiers (or ~56,000) work in the life sciences sector.  There is tremendous innovation happening right now at places like Purdue University where current president and former State of Indiana governor Mitch Daniels have done a tremendous job to accelerate innovation by creating a framework to spin up startup companies and pursue licensing opportunities with Purdue based research and intellectual property (IP).  For example, Purdue recently gained national press and media coverage when researchers recently deciphered the structure of the #Zika virus which will help to more quickly identify and develop therapeutics to treat it, while #GE and #Rolls Royce announced significant multi-year and multi-million dollar investments to further their partnership with the university and leverage engineering talent and facility capabilities to develop and built out new technologies related to jet engine research and advanced manufacturing.  Closer to Indianapolis mentioned was the 16 Tech project which will be anchored by the new $250M Indiana Bioscience Research Institute on 60 acres of land situated just northwest of downtown along Indiana Avenue between Indiana University School of Medicine, IUPUI and downtown Indianapolis, not to mention only 20 minutes from the Indianapolis International airport.  16 Tech will be designed as an #innovation hub and a conduit between life sciences research institutions, industry, expertise and facilities to foster and speed development of new products and technologies for medical innovation in Indiana.  Events like the IBJ Life Science Power Breakfast Series are important to showcase the progress we have collectively contributed as a state under the guise of not just as a national, but a global effort to push forward technology and breakthrough medical advances to help patients around the world.