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.

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:



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

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.

openFDA’s one year anniversary

It has been one year since FDA launched its initiative called ‘openFDA’. OpenFDA was an order brought by the White House to help others have access to the agency’s public data. One type of information users now have access to is FDA’s long list of application programming interfaces (APIs) such as medical device reports, approved drug labeling and many more.

FDA is hoping to spur more innovation not only throughout the agency but through the surrounding communities. Communities are the main reason that openFDA has been so successful, and FDA hopes to continue its success by involving them more through prioritizing which data the community is interested in.

To read more on Michael Mezher’s article in RAPS, click here.

FDA and Google joining forces?

The US Food and Drug Administration (FDA) and Google met last month to talk about a new ‘adverse event trending’ system.

FDA currently tracks adverse events in their FDA Adverse Event Report System (FAERS). However there are concerns that this system underreports since patient and doctor reporting to this system is voluntary. While it is mandatory for drug makers to report via FAERS, patients and doctors can as well; however, because this reporting is voluntary, many fear they are missing important adverse event trends.

Adverse reports are vital for drug safety for patients, as often is the case, not all adverse events are found during a clinical trial. To fix the underreporting problem, FDA has explored social media, search engine, and internet sources for additional information.

As reported by Michael Mezher on, FDA and senior leaders at Google met last month. Perhaps FDA is exploring how to collaborate with Google to develop a new system in drug-safety surveillance.

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

Congress officially passes the 21st Century Cares Act

On July 10th, the 21st Century Cares Act was passed which will increase the NIH and FDA funding. This increase in funds is to install a new framework for evaluating patience’s experience with drugs and to create a new national pediatrics research network and will be impacting CRO’s.

Those against this bill are worried about how the bill will be paid for and their affects of bring new cures to the market. Although the payment of the bill is not stated, many are looking forward to see how the bill will help the world.

To read more on Zachary Brennan’s article in outsourcing-pharma, click here.

What to know about FDA’s priority review vouchers

Since 2007, FDA has been issuing priority review vouchers for pharmaceutical products. In 2015 the newest priority review vouchers to focus on reducing time and cost of drug development. Developing a new drug takes a lot of time and money. In the United States, about every 1 in 10 drugs that reach the phase 1 clinical stage, get approved. Even if a drug does get approved it can take up to a year or more to receive the funding or find patients for clinical studies.

The reason for these vouchers is to spur drug development. The vouchers give a company the ability to have a drug reviewed under FDA’s priority review system. Ultimately these vouchers could lead to finding new drugs or a cure for many diseases, particularly rare or difficult to treat diseases.

To read more, check out Alexander Gaffney’s priority review vouchers article at and click here.