FDA announces requirements for compounding pharmacies

According to a recent announcement, FDA will require large compounding pharmacies to register annually, pay a $15,000 annual fee, and report a list of all manufactured products every six months. These requirements were established in three guidance documents, explaining how to comply with the regulations for outsourcing facilities.

A few key takeaways from the guidances include:

  • Compounders may withdraw their registration
  • Any registered compounder must re-register each year between October 31 and December 31
  • All outsourcing facilities must register and submit product reports through FDA’s electronic submission process. Email submissions will no longer be accepted.

FDA estimates at least 1,000 U.S. large compounders are eligible for registration; 51 have registered so far.

For more information, read Robert King’s article from FDAnews.com here.

Pearl Pathways announces global partnership with Brandwood Biomedical

Pearl Pathways is pleased to announce a partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia. This collaboration allows both companies to provide on-the-ground support to clients and better adapt to the changes and complexities associated with global markets. For more information, read our full press release here.

In addition, Pearl Pathways and Brandwood Biomedical will be hosting the The Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations featuring a variety of local experts from Asia-Pacific.

When: March 5-6, 2015

Where: Hilton San Diego Mission Valley Hotel

Register here before December 5 to enjoy the lowest early bird pricing!

We hope to see you in San Diego!

2014 IRB holiday schedule

Pearl IRB has Full Board meetings scheduled for December 3, 10, and 17. There will be no meetings on December 24 or 31. The regularly scheduled Full Board meetings will resume on January 7, 2015. If you have an urgent IRB concern, please contact us at least two weeks in advance. Happy holidays to all!

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.

Diana Caldwell to present at Central Indiana WBE Forum

Pearl Pathways’ own President and CEO, Diana Caldwell will be presenting at the Central Indiana Women’s Business Enterprise (WBE) Forum held in Indianapolis in November.The topic for this session is “5 Steps to Up Your Business Development Game.” Please join us for this exciting event!

CEED_WBEC_Logo - CopyWhen: Tuesday, November 18, 2014 from 10AM-1PM

Where: Mid-States MSDC Building, 2126 N. Meridian, Indianapolis, IN

Registration is FREE! Click here to RSVP before the November 14 deadline

This forum is presented by the Women’s Business Enterprise Council-Great Lakes (WBEC-GL), an initiative of the Center for Empowerment & Economic Development (CEED).

We hope to see you there on November 18th!

Pearl Pathways is hiring! Business Development position open

Effective immediately, Pearl Pathways (Indianapolis, IN) is accepting applications for a Business Development Director position. Please click here to view the complete job description. Proven sales and account management experience is required; additional experience in the life sciences field is preferred. If you are interested, please send your resume and all inquiries to contact@pearlpathways.com. For a complete list of career opportunities, 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.