Register for the IMDMC workshop on September 10th

On September 10th, the second part of the Indiana Medical Device Manufacturers Council two-day program, REG 102, will be hosted.

This program is designed to provide industry background and knowledge specific to FDA regulations to those who may be new to the industry or regulatory function. Pearl Pathways’ own, John Lockwood, will be speaking on inspections.

When: Thursday, September 10, 2015, 8:00 AM to 4:30 PM EDT

Where: The Montage (8580 Allison Pointe Boulevard, Indianapolis, IN 46250)

To read more details on the topics covered, visit the IMDMC website. To register for the event, click here.

Analysis confirms cause of FDA varied review times

As reported by Alexander Gaffney in RAPS in 2014, the Manhattan Institute of Policy Research (MIPR) claimed that the inconsistencies in review times at FDA were due to inefficiencies by the agency.

Since then, FDA has argued that the variations at the Center for Drug Evaluation and Research (CDER) were caused by accelerated review in specific areas and correlate to proportions of such.

After further data analysis of 250 new molecular entities (NME), it was found that the review time varied based on FDA prioritization of treatments, such as oncology vs. dermatology.

To read Michael Mezher’s full article, click here.

Pearl Pathways announces publishing of new case studies

Pearl Pathways is excited to announce the release of pharma, medical device, and new academic hospital case studies. This brings our total number of case studies to sixteen. Check out our dedicated case study website page here where you can learn through real life examples of how Pearl Pathways has created solutions for our clients. See something that sounds like a problem you are facing? Contact us now for a consultation. To view our case studies, click here.

Lessons learned from recent NIH 483s from FDA

The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) facility based on recent FDA 483s that were issued by FDA in May 2015. The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination after the batch was administered to patients.

Following the fungal contamination complaint, FDA inspected the National Institutes of Health manufacturing site in May of 2015. On June 4th, operations at the Pharmaceutical Development Section (PDS) at the NIH Clinical Center were suspended.

The recent FDA 483 issued to the PDS facility contained 17 detailed observations containing comments such as:

  • “Container closure integrity testing is not performed for any sterile drug products.”
  • “Insects were observed in two (2) of five (5) ISO 7 cleanroom ceiling light bays . . . .”
  • “There is no GMP training program . . . .”
  • “The quality unit is not involved in release of drug products . . . .”

The 483 issued to the NIH brings up several questions – some of which may not be able to be answered due to NIH’s lack of an effective monitoring process.

Who’s in charge of clinical trial manufacturing? How long has NIH been in noncompliance with the basic principles of cGMPs and aseptic processing? How many clinical trial subjects are at risk? What would have happened if this letter was received by a for-profit pharma company?

You can read more about this issue at in-Pharma: http://www.in-pharmatechnologist.com/Regulatory-Safety/House-to-FDA-who-s-in-charge-of-clinical-trial-manufacturing/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=10-Aug-2015&c=frllEubEPtKm0xrxglSmsg%3D%3D&p2

 

 

FDA says yes to 3-D drugs

Recently, the US Food and Drug Administration (FDA) has approved the first 3-D printed drug. This drug was created by a private company located in Pennsylvania and has up to 1,000mg of levetiracetam in it. The reason for this drug is to help those who have trouble swallowing pills. Many children, elderly and others have trouble swallowing pills, but thanks to this new pill they now only need one spill of liquid.

Before 3-D printing drugs was created, 3-D printing was used for medical devices and replicating organs. With the news of 3-D printing, many are hoping to create more drugs for those who have troubles swallowing.

To read more on Fiona Barry’s article in in-Pharma, click here.

FDA releases new 510(k) guidance

On August 5th, the US Food and Drug Administration (FDA) released a new guidance on 510(k) submissions. This guidance is called “Refuse to Accept Policy for 510(k)s” and the plan is for it to be in effect this October.

The reason for this new guidance is to provide more of a consistent acceptance amongst 510(k) submissions. The new changes include checklists, criteria for submission, as well as criteria for alternate submissions. FDA hopes the new guidance will help make submissions smooth to submit and accept in the future.

To read Michael Mezher’s full article in RAPS, click here. Need help with your 510(k) submission, contact our experts at contact@pearlpathways.com.

HBA features CEO Caldwell in a “meet the membership” newsletter series

President and CEO of Pearl Pathways, Diana Caldwell, was featured in the Health Businesswomen’s Association (HBA) “meet the membership series” in an email newsletter on July 20th, 2015. Caldwell was asked a series of questions relating to her start-up of Pearl Pathways and her personal motivators. Caldwell shared her favorite quote by Alan Cohen, “It takes a lot of courage to release the seemingly secure, to embrace the new. But there is no real security in what is no longer meaningful. There is more security in the adventurous and exciting, for in movement there is life, and in change there is power.”

The HBA’s mission is to “to further the advancement and impact of women in healthcare worldwide.” The HBA was created to connect women in business and have them come together to share career information and resources. This organization has been in existence for four decades and continues to strive to complete its mission.

To read the full interview on Diana Caldwell on HBA’s website, click here.

Quality Metric Guidance announced by FDA

This week the US Food and Drug Administration (FDA) released its draft guidance on how to advance risk-based inspections and improve issues with drug shortages. Earlier this year, FDA created the Office of Pharmaceutical Quality (OPQ) to help look at drug product and quality level. Many drug shortages are caused by manufacturer quality issues. The creation of the new office hopes to curtail future shortages and problems.

The new draft guidance aims to not only improve the quality of drugs, but decrease the amount of inspections needed.

To read more, check out Michael Mezher’s article in RAPS here.

Register now for the Indiana Clinical and Translational Science Institute

The Indiana Clinical and Translational Sciences Institute is hosting its 7th annual meeting on September 11, 2015. Young researchers will be recognized and a major highlight of the event will be the awarding of the second Watanabe Prize in Translational Research to the keynote speaker, Carl H. June M.D. To find out more about the event, go to Indiana Clinical and Translation Science Institutes website.

When: September 11thnew-ctsi-logo

Time: 8am-3pm

Where: Hine Hall on IUPUI’s campus in Indianapolis

Registeration is occurring now, to register click here!

Pearl announces 5 years of business

Pearl will be hosting a celebration for its 5 fantastic years of being in business. Pearl opened in 2010 to help fast-track therapeutics and diagnostics for patients in the life science industry. Refreshments and appetizers will be served.

When: August 6th, 2015Photo of 29 E. McCarty Pearl Pathways office

Time: 4:30-7:00pm

Where: 29 E McCarty Street, Indianapolis, IN

RSVP to sjancin@pearlpathways.com by July 31st.

We look forward to seeing you!