AAHRPP Accreditation further distinguishes the uniqueness of Pearl IRB

Pearl IRB becomes just the second AAHRPP accredited organization in the state of Indiana by demonstrating high standards of excellence for quality, ethics, and protection in all levels of research.

“We are extremely proud to have earned AAHRPP accreditation. Our clients want to work first and foremost with an IRB that demonstrates excellence, but many also have the business objective of engaging with diverse suppliers in the clinical research space. With Pearl IRB, they get both,” shares Pearl IRB’s President and CEO, Diana Caldwell.

Click here to read our full press release!

Gretchen Bowker will hold webinar on March 15th 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!

Upcoming Second Annual BSI Mini-Roadshow Event on April 16th in Chicago

BSI logoThe British Standards Institution (BSI), the world’s first national standards body to partner with medical device manufacturers is holding its second annual Mini-Roadshow program on April 16th. The event topics include:

  • European Regulatory Update – CE, 13485, OBL
  • Clinical Data Evaluation – Lesson’s Learned
  • Compliance Navigator & Action Manager
  • Technical Files – Key Pitfalls
  • UAV & MDSAP Update

Presenters: Paul Brooks, Ibim Tariah, and John Bis

What: BSI Medical Device Mini-Roadshow

Where: Chicago Marriott Naperville1801 North Naper Boulevard Naperville, IL 60563

When: April 16th, 2015 from 8:30AM – 12:30PM

 

Registration is FREE! To register and learn more, click here.

We hope to see you there on April 16th!

 

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.

FDA announces they will not regulate “low risk” general wellness devices

While mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness devices. Traditionally, medical devices are required to obtain FDA approval or provide evidence of similarity to a preexisting product. In a new draft guidance entitled General Wellness: Policy for Low Risk Devices, the Agency has confirmed their decision not to regulate products classified as “low risk general wellness.” FDA defines such products as “solely intended for a general audience and presenting a very low risk to users’ safety.” Some examples provided in the guidance include exercise equipment, sleep, stress, or weight management devices, and other physical fitness products intended for recreational use.

For more information, read Alexander Gaffney’s article on RAPS.org here.

RAPS.org Article Published by Pearl Employee

Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus.  The full article can be found 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, IVD classification can become complicated with an abundance of acronyms. 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. If you are involved in the development of IVDs, this is a must read article.

Read full article here on RAPS.org.

Pearl Pathways sponsoring, attending Asia-Pacific Device Summit in San Diego

Pearl Pathways is excited to sponsor its Asia partner and attend upcoming Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations. This conference provides an opportunity to network and hear first-hand accounts from several local experts from Asia-Pacific. Some of the topics include managing growth, ensuring sales, marketing, and regulatory compliance, and structuring for flexibility, compliance, and success. We invite you to join us at the event!

What: Asia-Pacific Device Summit

When: March 5th – 6th, 2015

Where: Hilton San Diego Mission Valley Hotel

Prices will go up in February, so register here today!

We hope to see you in San Diego!

New FDA Approach to Medical Device Accessory Regulation

FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The new FDA approach intends to classify the risk of the device when used with the parent device, as intended. In theory, this will provide a more accurate risk classification for the accessory devices, thus assuring the safety and effectiveness of the device.

In order to get new medical device accessories to the market more promptly, the guidance suggests that manufacturers use the de novo classification process to classify new types of device accessories.

Need help mapping out the regulatory path for your medical device accessory? Contact us at contact@pearlpathway.com.

To read Alexander Gaffney’s full article on raps.org, click here.

Webinar on 8 tips for Asia Pacific regulatory success – February 5th

Do you find the market entry in Asia Pacific challenging? Pearl Pathways’ Asia partner, Brandwood Biomedical will be hosting a webinar highlighting common traps and tips for regulatory success in the challenging Asia Pacific market.

What: Live webinar exploring the 8 tips for Asia Pacific regulatory success

When: Thursday, February 5th, 2015 12:00PM – 12:30PM EST

Follow the link and register here today!

All participants in the webinar will receive a 5% discount to the Asia Pacific Devices Summit on March 5th-6th, 2015 in San Diego.  For additional details about the summit, click here.