Pearl Pathways attending, sponsoring IMDMC annual conference – November 6

imdmcPearl Pathways is excited to be attending and sponsoring the IMDMC Annual Conference tomorrow, November 6 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the medical device industry. Dr. Kimber Richter from the FDA Office of Compliance will present this year’s keynote speech on “FDA Assessment of Risk/Benefit in the post Market/Recall Space.”

When: Thursday, November 6

Where: Montague Banquet Center, 8580 Allison Pointe Blvd, Indianapolis, IN

We encourage you to stop by our exhibitor booth to meet our talented staff! For more information about IMDMC, click here.

New FDA guidance says new fixed-dose combination drugs are eligible for exclusivity

For the first time, FDA is allowing new fixed-dose combination (FDC) drugs to be eligible for five years of New Chemical Entity (NCE) exclusivity. FDA currently provides market-based exclusivity to pharma companies who have been approved to market new drugs, granting them patent protection and disapproving any outside equivalents over a five-year period. Until now, FDC drug products have been ineligible for five-year exclusivity if they consist of any previously approved entities.

FDA has recently released a final guidance document outlining the new standards for exclusivity. While industry’s reaction was seemingly positive, many companies have expressed concerns with the new policy’s lack of retroactivity. FDA explains in the guidance that these new exclusivity standards will only be effective as of October 10, 2014, which is when the document was published, meaning that FDC drugs with prior approval will remain ineligible for this exclusivity.

To learn more, read Alexander Gaffney’s article on raps.org. Click here to read FDA’s final guidance.

New whitepaper from Pearl Pathways “Types of In Vitro Diagnostics: Clearing up the Confusion”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much can be easily understood: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are many roadblocks to bringing a medical device to market, but spending time on product classification and sifting through FDA guidance documents doesn’t have to be one of them.

Pearl Pathways has published a new whitepaper entitled “Types of In Vitro Diagnostics: Clearing up the Confusion.” The paper discusses the many categories of IVDs and their requirements and regulations. These categories include RUOs, IUOs, ASRs, LDTs, Companion Diagnostics, and IVDMIAs. This paper is a must read for anyone involved in the development of IVDs.

Click here to read!

Pearl Pathways to attend, present at 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Pearl Pathways is excited to be attending 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’s 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!

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.

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.

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.

FDA releases final guidance on companion diagnostics

FDA has recently released a final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products, which are used in conjunction with therapeutic or biological products to maximize effectiveness based on the genetic characteristics of a patient or population. Companion diagnostic products have become more common in the past few years and provide great benefits to both regulators and industry.

Regulators find that diagnostics make it easier to determine which patient populations will benefit, and reduce the risk of drugs being used improperly or on untested patients. In turn, this information helps regulators see who could potentially benefit from a drug and why, ultimately simplifying the approval process for drug manufacturers.

The final guidance provides clarification on policies from the original draft guidance that may have been unclear, but is otherwise the same. According to the guidance, although FDA may approve some drugs without a companion diagnostic device, “in most circumstances an IVD companion diagnostic device and its corresponding therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling” in order to ensure safety and efficacy.

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

FDA proposes new regulatory framework for Lab-developed Tests

Through a recent draft guidance, FDA has proposed a new risk-based regulatory framework for Lab-developed Tests (LDTs), comparable to existing policies for in vitro diagnostic devices (IVDs).

Historically, LDTs have been developed at low-risk for the diagnosis of rare conditions with the intent to be used within a single organization, and therefore have not been required to obtain FDA approval as IVDs have. The agency has recently noticed an increase in complexity among LDTs, which raises the risk of inaccurate diagnoses, and has ultimately driven FDA to pursue more strict regulation.

On July 31, FDA submitted the guidance, Framework for Regulatory Oversight of LDTs, proposing a risk-based system for regulation. Those classified as “low risk” or intended to diagnose rare diseases will be exempt from most of the regulations, while high and moderate risk LDTs will be subject to more strict requirements.

  • Low-risk (Class I): must meet FDA requirements for registration, device listing, and adverse event reporting.
  • Moderate-risk (Class II): must meet all Class I requirements and begin reporting adverse events within six months of the final guidance. Class II devices will also need to go through premarket review beginning five years after the guidance is finalized.
  • High-risk (Class III): will also need to begin reporting adverse events within six months and those devices with the “highest risk” will also require marketed review beginning one year after the guidance, while the remaining “high-risk” devices will be reviewed over the course of four years.

Following the guidance submission, various medical groups, politicians, and industry representatives have expressed concerns with FDA’s approach; many noting the importance of timely, and innovative diagnostic technologies for quality patient care.

 

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

Read Andrew Pollack’s article in the NY Times here.

Also read Varun Saxena’s article on fiercemedicaldevices.com here.

Pearl Pathways sponsors Indiana Life Sciences Conference Series

life sciencesPearl Pathways is proud to sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, 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.

Please join us for this year’s first conference on September 12th entitled An Update on the FDA and Global Regulatory Bodies, 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.

 

To learn more about the Indiana Life Sciences Conference Series, click here.