Obama nominates Robert Califf as FDA commissioner

With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner.

Concurrently, the US Senate is working to permanently expedite the process of FDA drug approval through legislation. For Zachary Brennan’s full article, click here. For an additional article on this topic, check out Medscape.

Pearl Employee Publishes Article on RAPS.org

Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus.  The article is located on RAPS.org (Login and Password required) and is entitled Types of In Vitro Diagnostics: Clearing Up the Confusion.”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. This is easily understood – however, with an abundance of acronyms, IVD classification can become complicated. To clear up the confusion, this article considers six types of IVDs:

  • Research Use Only (RUO)
  • Investigational Use Only (IUO)
  • Analyte-Specific Reagents (ASRs)
  • Laboratory-Developed Tests (LDTs)
  • Companion Diagnostic IVDs
  • In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)

There are a number of hurdles to bringing a new medical device to the market, but product classification does not have to be one of them.  This article is a must read for anyone involved in the development of IVDs. Read full article on RAPS.org here.

Join Pearl Pathways at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Pearl Pathways is excited to be attending and presenting at the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to successfully bring a companion diagnostic to market. This year’s attendees include FDA reviewers, accomplished industry representatives, and numerous regulatory experts.

We encourage you to stop by our booth to meet our talented staff. In addition, we invite you to join us for the Clinical & Regulatory Strategies for Companion Diagnostics Workshop on Wednesday, October 29. Pearl Pathways’ own Gretchen Bowker will be serving as the moderator for the 11:20 discussion on Establishing Realistic Timelines for Companion Diagnostics & Personalized Medicine Development.

Click here to register for the conference. We hope to see you in Alexandria on Monday!

2014 RAPS features Gretchen Bowker as a speaker

Pearl Pathways’ own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and responsibilities of sponsors, investigators, IRBs, and regulatory authorities as they relate to the development of biologic products.


What: Regulatory Strategy Forum for Biologics

When: 9 a.m. to 5 p.m. on Saturday, September 27

Where: 2014 RAPS Preconference Workshops (Meeting Room 16A)

Register here!


We hope to see you soon at 2014 RAPS: The Regulatory Convergence in Austin!

FDA adopt guidelines from ICH

Alexander Gaffney from raps.org has just released an article on regulators releasing the latest guideline on electronically transmitting individual case safety reports (ICSR) from the International Conference on Harmonisation’s (ICH). ICH is a pharmaceutical harmonization group that is run by US FDA, European Medicine Agency (EMA), and Japan’s Ministry of Health, Labor and Welfare (MHLW). ICH aims to have regulatory processes better align with different administrations allowing for greater efficiency between industry and regulators. The final guideline, E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification, provides an outline for the data, terminology, and exchange standards for ICSR submissions to improve the quality of data and improve the analysis of the documents. To read the full article click here.

Setback for EMA’s vision of transparency

Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public information. This is a setback for the EMA, whose goal is to make public all clinical and non-clinical data.  Proponents of data transparency include the people behind the AllTrials campaign, whom have the same goals as the EMA. Companies such as Abbvie and Intermune, leaders in drug and medicine innovation, have fought the idea of transparency. They have sued the EMA on grounds that the information publicized is “commercially confidential information”, in which the EU court agreed with.  EMA’s head of communication, Mark Harvey, commented on the situation via Twitter saying “disappointing, but not the end”. EMA will appeal the court’s ruling and continue with their battle to make all data and information publicly available. Is this the next step in clinical data? To read the full article click here.

Save the Date: February 25, 2013 RAPS Indiana Chapter networking event

Join Pearl Staff at the ‘Celebration of Life Sciences in Indiana Networking Reception’ hosted by the RAPS Indiana Chapter.  The focus of the event is to promote new connections among local regulatory professionals. A BioCrossroads representative will also provide an update about the life sciences in Indiana.

What: Celebration of Life Sciences in Indiana Networking Reception

When: February 25, 2013

Time: 4:30-6:30pm

Where: Faegre Baker Daniels LLP, 600 E. 96th Street Suite 600, Indianapolis, IN

Directions are available online or by calling +1 317 569 9600

Contact Cindy Killion at cynthia.killion@faegrebd.com to RSVP.

To learn more about RAPS Indiana, click here.

September 11, 2012–RAPS presents “The New FDA Landscape in Medical Device Development”

The RAPS Indiana Chapter presents the expert presentation, “The New FDA Landscape in Medical Device Development.”

Where: MED Institute Inc., West Lafayette, IN

When: September 11, 2012 from 5:15 – 8 p.m.

Cost: $40 for non-members and $25 for members

Stay current on FDA activities that are affecting device development and exchange ideas with other local regulatory professionals.

This interactive discussion will include a meal for all participants, and attendees may claim two RAC recertification points.

To register and learn more about this event, click here.

Tuesday, June 26th–RAPS presents expert presentation!

The Indiana chapter of RAPS presents an expert presentation entitled, “Steps to Preparing for a Successful FDA Advisory Committee Meeting!”

Pearl’s own Gretchen Bowker, RAC, FRAPS  is the Indiana RAPS Chapter Chair.

When: June 26, 2012 from 4 – 6:30 pm

Where: Indiana University Emerging Technology Center in Indianapolis, IN

Cost: $15 for members and $30 for non-members

There will be a light meal provided for all meeting participants and attendees may claim two RAC recertification points.

To register for this event, click here. For more information about this event, click here.

RAPS Indiana Chapter Event: May 14th, 2012

Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event.  The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room.  To register, click here.