Update on OTC Drug User Fee program activity

FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff of 18 employees to manage.  The idea is that implementing a user fee program may result in great benefits and advances in over-the-counter drugs to help us manage symptoms and conditions safely without the oversight of a doctor.

Zachary Brennan, RAPS, posted an article that has additional informative links that follow the current FDA activity on this topic.  Brennan indicates that FDA is still seeking input/perspectives from stakeholders as they work toward a more defined approach.  Help them take a first “bite” into this huge project by commenting.

Using Comparability Protocols for CMC postapproval changes

FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change. FDA defines a CP as a comprehensive plan for “assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” When assessing how a CMC change may affect product quality under a CP, be sure to have the following established for continuous improvement:

  • An understanding of the product and manufacturing process
  • A robust control strategy
  • Risk management activities over a product’s life cycle
  • An effective pharmaceutical quality system

 

For more information, read Dan Stanton’s article at in-PharmaTechnologist. Let Pearl Pathways help you with your CMC approach and regulatory submissions for both drug substance and drug product. Contact us here.

Deadline fast approaching for Class II medical device compliance with UDI

September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID (Global Unique Device Identifier Database). Device labeling documentation planning is key since once the DI is submitted for a device and entered into the GUDID; further, there are rules for editing during a grace period only and companies may find themselves in situations requiring them to have to obtain a new DI for a device. Keep watching for any FDA updates that may post as this deadline approaches.

More details can be found in Michael Mezher’s informative article posted on RAPS. Pearl Pathways has an experienced team ready to help with your UDI compliance planning and execution, contact us here.

What is your company doing about Cybersecurity for Medical Devices?

cybersecurityEarlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software (firmware) and includes the ever important postmarket management. Risk to device functionality or loss of important data due to a cybersecurity risk is a consideration that could result in bad outcomes for patients. Device manufacturers need to take a look at their own risk management programs and assure they have a comprehensive plan established.

Pearl Pathways looks forward to the opportunity to work with you and provide support to your ongoing successful product development activities including risk management program development as part of your overall Quality System. Contact us to set up a discussion.

Image courtesy of thomasdinnocenzi.wordpress.com

Gretchen Bowker speaking at the IMDMC REG 101 workshop on April 21st

imdmcThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st for those new to the medical device industry or for those looking for a regulatory refresher. Pearl Pathways’ own, Gretchen Bowker COO & RAC, FRAPS, will be presenting on, Pathways to Market – 510(K) Requirements at 10:15am. The workshop provides a background in FDA regulations of medical devices.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Thursday, April 21st, 2016, 8:00 AM to 5:00 PM EDT

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

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today! (Lunch will be provided.)

To learn more about the workshop and register for REG 101 & 102 Workshop, click here. We hope to see you there on April 21st!

Bill passed Senate that would add the Zika virus to FDA’s list for priority review vouchers

Last week, the US Senate added the Zika Virus to the priority review voucher (PRV) program for FDA.  It could be the 22nd tropical disease on the list if the bill passes in the House which seems likely. Zachery Brennan published a comprehensive article on this topic which shares a good history on the program.

While the Senate and Congress seem to be big fans of the PRV program, not all industry experts completely support this program which gives corporations who apply and earn the vouchers the ability to cut the FDA review period from 10 months to 6 months, or, they can sell them for hundreds of millions of dollars on the market.  FDA’s established opposition to the program is reviewed in an article earlier this month on www.raps.org .

Need help navigating which rare, neglected, and tropical diseases are eligible for PRVs?  Contact our staff, we can help.

Slower roll-out of UDI System

FDA’s unique device identification (UDI) system, established in 2013 as a means to identify and track devices through distribution and use, is taking some time for implementation. The UDI system was expected to be implemented in stages over a seven-year period to allow for manufacturers to comply. In establishing this system, the goal is to have device data available electronically, to reduce medical errors, and to have more accurate reporting of adverse events for a more rapid solution to reported problems and FDA communications to the public.

This transition to UDI on the labeling is a costly and difficult change for the industry in its device labeling documentation. The rule requires a UDI be provided on the device label using automatic identification and data capture (AIDC) technology so that it can be automatically entered into an electronic patient record or other computer system for tracking. FDA is extending deadlines, according to Michael Mezher, RAPS. Read his entire article here for details on dates and specific devices included in the FDA extensions. The patient comes first and the extensions seem to be necessary to avoid any problems with patient access to devices.

FDA working to address its backlog of tracking postmarket safety work

According to an article by Zachary Brennan, RAPS, the Government Accountability Office (GAO) issued a report in December 2015 that in review of the Document Archiving, Reporting and Regulatory Tracking System (DARRTS), the FDA has not formally tracked 144 issues relating to Fast Track and Breakthrough Therapy drugs. It was reported that the backlog needs to be tackled for drug safety oversight. The report further details that FDA does not yet have a full comprehensive plan in place with defined goals and timelines to address these problems identified.

Brennan’s article states FDA response is “First, the agency says that all drugs must meet the same statutory standards for safety and effectiveness, regardless of their expedited status. Second, drugs authorized through expedited pathways do not necessarily require different postmarket studies than other drugs approved through standard pathways, and finally, FDA says it’s working to address “challenges related to administrative tracking of its postmarket safety work.”

So, sometimes the best plans need revisions and the GAO study recommends FDA develop a comprehensive plan to address issues identified. Let’s keep moving forward on a safe and accelerated process for drug development to get therapies in the hands of the patients who have no other options. Pearl Pathways is on track to help you accelerate your drug development process in a safe, guided manner. Let’s work together, contact us.

What are the lessons learned from the dirty scopes investigation?

Our recent blog post, Medical Device “Emerging Signals”, updated about FDA’s intent to notify the public about “new information about a medical device used in clinical practice”. FDA’s intent to alert the public to the most current information known about a medical device to prevent potential risk to patients is a good concept — implementation requires cooperation from hospitals and medical device manufacturers.

In a blog entry posted January 13, 2016, Michael Mezher, RAPS, addressed a Senate report released on duodenoscopes that were found to be the source of infection in patients. In Mezher’s article, the report found hospitals did not report safety issues in a timely fashion to the medical device manufacturers who were then to report to FDA. Also, it was found that there were no reports in design changes that were made to the scope from the device manufacturers. The delays in reporting safety issues and design changes without review meant patients were at risk because the scopes were still in use.

Lessons learned – more oversight, guidance and improvements in reporting can be made for better outcomes. The report makes recommendations for the FDA to determine if a design change is necessary on the scopes, require unique device identifiers (UDIs) to improve device monitoring, and update guidance on when device manufacturers need to submit a new 510(k) for device modifications.  These recommendations were made in efforts to improve safety on medical devices.

FDA’s emerging signals draft guidance is a step to transparency and may result in less risk to patient health. The patient is counting on hospitals, device manufacturers and FDA working together responsibly.

To read Mezher’s complete article on RAPS.org, please click here. Contact us if you need regulatory filing assistance or quality system support to ensure your Medical Device Reporting (MDR) processes are compliant.

Medical Device “Emerging Signals”

The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices. FDA defines an emerging signal as “new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”

An “emerging signal” would alert the public to the most current information known about a medical device. The intent is to prevent potential risk to patients. Opponents to this idea are asking why the FDA would release information that has not been fully verified / investigated by the FDA. For more information, read Zachary Brennan’s article on RAPS.org.