FDA to go paperless with its new drug advertising review process

FDA releases new draft guidance in April 2015 entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drug. The purpose of this guidance is to make it easier for marketing professionals in the pharmaceutical industry to submit their advertisements and promotional materials for review and approval. Traditionally, FDA’s Office of Prescription Drug Promotion (OPDP) required pharmaceutical companies to submit their materials using a paper-based for known as the Form FDA 2253. As these companies are increasingly using electronic media such as websites, emails, social media, etc. to promote a drug, OPDP is proposing the idea of using its electronic common technical document (eCTD) format instead. Two years following the finalized document, all companies will be required to submit their advertisements and promotional materials using OPDP’s electronic form.

If you would like to submit comments to FDA regarding this draft guidance, be sure to submit here by July 21, 2015.

Click here to read FDA guidance document. For additional information, read Alexander Gaffney’s article on RAPS.org.

FDA to release draft guidance on approving medical devices using foreign trial data

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.

Such medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:

  • Detailed information about the research facilities and qualifications of the trial’s clinical investigators
  • Protocol and results summary
  • Full description of the device
  • Demonstration of the scientific validity for all of the gathered data
  • Ample assurances concerning informed consent

Ultimately, this guide document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.

To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.

FDA finalizes plan for an accelerated review program involving critical medical devices

As of April 15, 2015, a year after its initial proposal, FDA will begin to accept applications to participate in its new accelerated review program. The program is intended for critical devices defined as, “devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” FDA plans to increase access to resources including senior management and case managers in order to leapfrog the acceleration review process. Ultimately, this accelerated review program will provide an avenue for potential life-saving devices to reach those patients in need sooner.

To learn more, read FDA’s guidance here.

Pearl Pathways sponsoring, attending IVD Conference in San Diego

Q1 Prodcution LogoPearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on the FDA pathway for next generation sequencing, clinical and regulatory lessons learned in bringing a companion diagnostic to the market, and how to properly prepare for regulatory hurdles outside the United States. Pearl’s own Gretchen Bowker, Co-Founder and COO, will be presenting on ‘Interpreting and Applying FDA Draft Guidance’ at the event.


What: Q1 Productions’ 6th Semi-Annual IVD West Conference

When: May 4-5, 2015

Where: Hilton San Diego Harbor Island – 1960 Harbor Island Drive, San Diego, CA

Pearl Pathways is offering discounted tickets for the event. For more information or to arrange to join us at this event, please contact our Director of Business Development, Chad Pannucci at cpannucci@pearlpathways.com.

Click here to register today. We hope to see you in San Diego!

New FDA Guidance on Critical Path Innovation Meetings

FDA releases new guidance document in April 2015 regarding Critical Path Innovation Meetings (CPIM). The document strives to provide insight to pharmaceutical companies and the public regarding the acceleration of the drug development process through the Critical Path Initiative. CPIM are designed to communicate with industry experts, patient advocacy groups, and government to improve efficiency and success in drug development. The meetings allow FDA to provide its perspective on the use of proposed new tools and methods in drug development as well as gain exposure to new techniques that have potential value in the drug development process. Furthermore, the guidance provides examples of appropriate topics for Critical Path Innovation Meetings and the information needed to request a meeting.

To access FDA guidance document, click here. For additional information, read Alexander Gaffney’s article from RAPS.org.

FDA requires additional label warnings on multi-dose diabetes pens

To reduce the serious risk of spreading infections and ensure insulin pens and other injectable diabetes medicines are being used appropriately, FDA is mandating these injectable devices display the warning label “For single patient use only.”  Multi-dose pen devices are designed to be administered to a single patient multiple times, not multiple patients. The sharing of these devices amongst multiple patients significantly increases the risk of infection spreading. Over the last seven years, thousands of patients have potentially been victims to infections transmitted through the sharing of these multi-dose injectable devices. The “For single patient use only” warning label is intended to greatly reduce the risk of spreading infection amongst patients.

Click here to read FDA’s full safety announcement.

Upcoming IMDMC workshop on Inspection Readiness featuring Pearl Pathways’ own, Heidi Strunk

imdmcPearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop will provide an opportunity to hear from experts who will explore the FDA inspection process and offer tips on what you need to know and how to be prepared for an FDA inspection.

What: An exploration of all the perspectives of the FDA inspection process.

When: Wednesday, April 15th, 2015 8:30AM – 4:30PM EST

Where: Montage Banquet Center, Indianapolis, IN            

Are you ready for a FDA inspection? Do you want to learn more about the inspection process? To register for the workshop, click here! (Lunch will be provided.)

Click here to learn more about the workshop! We hope you join us on April 15th!

Gretchen Bowker will hold webinar on March 19th via ComplianceOnline

ComplianceOnline logoPearl Pathways’ own COO and Co-Founder, Gretchen Bowker will be holding a webinar on FDA regulatory requirements for the manufacturing and commercialization of dietary supplements via ComplianceOnline. A few of the topics include a review of FDA regulations in the area, history of Dietary Supplement Health and Education Act, and a review of applicable FDA guidance documents. For more information about the webinar, click here.


What: A Discussion on Nutraceuticals/Dietary Supplements and FDA Regulatory Submission and Manufacturing Quality Requirements

When: March 19th, 2015 1:00 PM EST

Where: ComplianceOnline

To register for the webinar, click here!

Do you plan to launch a product into this rapidly growing market? Are you responsible for the manufacturing or distribution of a dietary supplement, food drug, or nutraceutical? If yes, this is the webinar will be informative and valuable for you!

We hope you join us for the webinar!

FDA proposes new regulations for drug commercials

Since the release of FDA’s “fair balance” doctrine, which requires drug companies to split the length of a TV commercial equally between benefits and risks, many have questioned whether this policy is hurting or helping consumers. In a recent notice FDA explains, “There is concern that in direct-to-consumer ads, the major statement is too long, which may result in reduced comprehension, minimization of important risks, and potentially therapeutic non-compliance due to fear of side effects.”

With this in mind, FDA has proposed a change in regulation that would require companies to only list the most prominent side effects in the drug’s major statement while still providing consumers with information on risks that are “serious and actionable.”

Before going forward with these proposed changes, FDA has announced plans to conduct a study to “investigate the effectiveness of limited risks plus disclosure strategy.” Participants in the study will be presented with one of four advertisements, each ad will provide a different level of risk disclosure.

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

FDA unveils new database for guidance documents

To kick off 2015, FDA has revealed a new database of guidance documents issued by the agency. An improvement on FDA’s prior organization system, the new database provides an up-to-date, user friendly, unified list of many guidance documents issued by all offices and centers within the agency. The system also provides multiple search functions that allow users to find documents by product type or FDA office. Further improvements to the database are to be expected, including additional information from FDA operation manuals, compliance guides, and alerts.

To access FDA’s guidance database, click here. For more information, read Alexander Gaffney’s article from RAPS.org here.