FDA moves to reduce cybersecurity threats in medical devices

FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests that manufacturers identify potential security risks and submit action plans to FDA to reduce vulnerability.

FDA’s additional partnership with the NH-ISAC will help foster the relationship between healthcare providers and security experts and provide programs to further minimize cyber-security threats. These threats came to light last year when two Department of Homeland Security researchers discovered a hard-coded password vulnerability affecting approximately 300 medical devices.

Click here to read Patrick Ouellette’s article on healthitsecurity.com. For additional information, read FDA’s final guidance and memorandum of understanding with the NH-ISAC.

NICE is pursuing more transparency from pharma companies

The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s primary auditor for drug products, ultimately deciding whether or not the value and efficacy of each drug is worth the cost. With this information, it is evident why pharma companies have historically expended a significant amount of resources toward staying within NICE’s good graces; however, the Institute has recently released a statement and corresponding guidance requesting more transparency.

NICE has established a requirement for new drug submissions to include a signed document “declaring that all clinical trial data have been identified.” If the data provided by the submitter is deemed insufficient for the drug appraisal process, the agency will contact the European regulatory authorities directly to obtain the information, as NICE’s statement suggests.

Although these new requirements will likely add to the existing tension between the agency and major pharma companies, NICE hopes to see an upward trend in transparency as part of the AllTrials campaign effort to register and report the results of all past and present clinical trials.

Click here to read NICE’s statement. For more information, read Arlene Weintraub’s article on fiercepharma.com.

New FDA study to examine the effects of distractions in drug ads

FDA has been granted approval to move forward with a May 2014 study proposal to analyze the effects of distractions in drug advertisements. In the study announcement FDA explains, “We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”

To conduct the study, FDA has created two drug advertisements: one with minimal distractions and the other with significant distractions. As each ad plays, the viewers’ eye positioning and movement will be examined to determine if the major risk statement is appropriately recognized.

Click here to read FDA’s study announcement. For additional information, refer to Alexander Gaffney’s article on raps.org.

Gretchen Bowker to speak at 2014 RAPS

Pearl Pathways is pleased to announce that our 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!

Diana Caldwell to be featured at 2014 Site Solutions Summit

Pearl Pathways’ own President and CEO, Diana Caldwell will be featured at the 2014 Site Solutions Summit as a moderator for the Crowdsolving topic entitled Tweet, Post, Like, Engage In Social Media For Results. In aligmnent with the structure of Crowdsolving sessions, Diana will be joined by a cross section of expert panelists, who will provide unique perspectives on your sites’ pain-points. The session will be highly interactive with attendees.  Diana’s industry and social media expertise provides valuable insight into creating best site practices.


Session Type: Crowdsolving

Title: Tweet, Post, Like, Engage in Social Media for Results

Date: Saturday, October 11, 2014

Start Time: 3:15 p.m. – 4:15 p.m.

For more information, please refer to the 2014 Site Solutions Summit agenda.


Register now and save! As a special guest of Pearl Pathways, we invite you to save $200 on the Standard Registration Price of $1597.  Please email mkillion@pearlpathways.com if you are interested and we’ll provide you with our discount code. We hope to see you at Amelia Island in October!

FDA announces new “Purple Book” for biological products

Similar to the pharmaceutical “Orange Book,” FDA has recently published the first edition of the “Purple Book” of biological products, which is intended to provide the regulatory community with information on the interchangeability of biosimilars.

The book is divided between two sections: products approved by the Center for Drug Evaluation and Research (CDER) and products approved by the Center for Biologics Evaluation and Research (CBER), and contains information such as the BLA number, product name, date of licensure, reference product exclusivity date, withdrawn, and more. In addition, FDA has proposed a four-tier assessment for biosimilar interchangeability, which presents the implication that not all products approved through the 351(k) biosimilar process will be considered interchangeable by the agency’s standards.

Although the U.S. market for biosimilar products is relatively small, FDA expects to see many additions to the Purple Book in the near future.

Click here to read Alexander Gaffney’s full article from RAPS.org.

Pathways’ co-founders speaking at Indiana Life Sciences Conference Series Event

In addition to sponsoring the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways is proud to announce that both of our co-founders, Diana Caldwell and Gretchen Bowker, will be serving as moderators for this year’s first conference entitled An Update on the FDA and Global Regulatory Bodies. We invite you to join us at the event on Friday, September 12th, where a panel of experienced industry professionals will discuss the potential affects of new approval procedures and quality compliance requirements.

What: An Update on the FDA and Global Regulatory Bodies

Where: IU Robert H. McKinney School of Law, 530 W. New York Street, Indianapolis

When: September 12, 2014 8:00am-3:15pm

Click here for the registration link.

The Indiana Life Sciences Conference Series is presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss important business strategies and solutions to promote the advancement of the life sciences field. To learn more, click here.

Diana Caldwell to serve as panelist for upcoming Kelley School career event

The Kelley School of Business Indianapolis Career Network is hosting a Career Momentum Event featuring Pearl Pathways’ own President and CEO, Diana Caldwell as a panelist. This event provides the opportunity to network with experienced executives and gain expert insight on how to push your career to the next level. We encourage you to join us on Thursday, September 11 from 5:30pm-8:00pm at the IU Advancement Office in Indianapolis. Register today!

As stated on their website, the Kelley School of Business Career Networks are an initiative to build strong, industry-focused networks in communities throughout the country. Career Networks is focused on meaningful events, in a professional environment, with the objective of utilizing the Kelley Network for career advancement.

Pearl Pathways recognized at 2014 Indiana Companies to Watch Ceremony

CTWCheers! On Wednesday August 20th, Pearl Pathways was honored as one of the 2014 Indiana Companies to Watch at the seventh annual awards ceremony held at the Indiana Roof Ballroom. Companies to Watch is a program that recognizes privately held businesses that have demonstrated exceptional growth and established a solid foundation for future development. Upon accepting the award, Pearl Pathways’ President and CEO, Diana Caldwell (pictured) shared, “Pearl is honored to stand among such an esteemed class of companies representing the state of Indiana. We are confident in the foundation that we have established to foster our continuous growth in the life sciences industry.”

To learn more about Companies to Watch, read ISBDC’s announcement of this year’s winners. To read our initial press release, click here.

FDA proposes to exempt 107 medical devices with new draft guidance

In an effort to simplify the approval process for low-risk medical products, FDA has exempted 107 medical devices from its 510k premarket notification regulations. This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and efficacy” to be marketed without a 510k submission, given that the device meets all other regulatory requirements.

FDA has granted exemptions for medical devices such as portable air compressors, fluid-filled teething rings, surgical lights, and obstetrical forceps.

To read Joseph Keenan’s article on Fierce Medical Devices, click here.