Cosmetic Registration Reports

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About Blog FWQRC Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influencers

The information in the tables below is a monthly report of activity in FDA’s Voluntary Cosmetic Registration Program (VCRP)

VCRP Monthly Status Report

Because the law does not require cosmetic firms to register their establishments or file their product formulations with FDA, participation in this program is voluntary. For this reason, the information below does not indicate the total number of companies manufacturing or marketing cosmetics in this country, or all cosmetic products on the market.

Activity for December 2019

• Number of online accounts activated this month: 103
• Number of products filed this month: 593
• Total activity since the launch of the new online system, September 20, 2018
• Number of active online accounts: 2,816
• Number of active cosmetic establishment registrations: 1,395
• Number of labelers that have filed product formulations*: 650
• Number of filed products: 8,333
• Number of product formulations discontinued**: 373
• Number of product formulations rejected***: 958
• Total activity since the VCRP was established, in 1972
• Number of active cosmetic establishment registrations: 4,392
• Number of labelers that have filed product formulations*: 3,071
• Number of active products on file: 68,838
• Number of product formulations discontinued**: 82,094
• Number of product formulations rejected***: 5,101

FWQRC™ intended to provide a decision pathway for drug & medical devices manufacturers in their first steps towards implementation of eCTD publishing and submission

Hi, Welcome to FWQRC™ Regulatory Focus News Letter

About Blog: FWQRC™ Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influences

Many of us aware that eCTD is mandatory for DMF submissions from Jan 2020.

• At the beginning of the decision process it is very important to make an evaluation of the current submission processes (“where are we”) in comparison with the eCTD requirements (“where do we need to be”).
• The conclusions drawn from this analysis, together with a careful evaluation of the boundary conditions within the company are the basis for the definition of the User Requirements Specifications (URS). 
• In the URS all the needs and boundaries of the expected processes are described and this information is used to find the optimal solution.Three possible solutions are described in detail, with their related advantages and disadvantages

1. In-house software,
2. Software as a Service (SaaS) and
3. Outsourcing  

• The last step of the process is the implementation of the chosen solution.
• It has to be considered whether a consultant should help with the creation of this URS document. Especially for the generation of the new processes the experience of a consultant can be helpfulThe URS is part of the official validation documentation according to GAMP and should be established for any new system

• Selection of solution

• Once the URS has been finalised, the most suitable solution has to be found.  For this analysis the URS requirements should be classified in some way, e.g. “crucial” and “nice to have”.

• The three possible solutions (In-house Software, Software as a Service and Outsourcing) are described in detail in the following sections.  Table 1 compares the most relevant characteristics of the 3 solutions, Table 2: Running an eCTD software system in-house: advantages and disadvantages and Table 3: Host system option: advantages and disadvantages

Table 1: Comparison of the 3 solutions

Item	In-House software	Software as a Service	Outsourcing
Freedom of configuration	High	limited	No
Responsibility for update and Maintenance	High	No	No
IT support in-house needed	Yes	No	No
Link to other IT systems in-house possible	Yes	No	No
Initial costs	High	Low	No
Ongoing costs	In-house	Yes	Yes
Lead time	Long	Medium	Short
Scalability	Depends on set-up	Easy	Easy
Need of resources and competence for use of eCTD software	Yes	Yes	No
confidentiality / data security issues	No	Yes	Yes

Table 2: Running an eCTD software system in-house: advantages and disadvantages

Advantages	Disadvantages
Full freedom for configuration	High initial costs for setting up the system
Free choice of hardware and software components	Relatively long lead time needed to set up the system
The software is part of the company-owned software and fits into the IT concept of the company	Full responsibility for update and maintenance
Everything stays in house (no data-transfer via internet / confidentiality etc.)	Personnel for technical set-up and maintenance must be available.
Link-up to other IT-systems possible (e.g. SAP)
Maintenance costs stay in-house
On-going costs are lower compared to the host software or outsourcing options

Table 3: Host system option: advantages and disadvantages

Advantages	Disadvantages
Speed: time from the decision to a pilot eCTD is often shorter compared to the in-house software solution	Dependency on an external partner which increases if also the DMS shall be hosted
Lower cost for initial implementation as there is no or a smaller initial investment (e.g. initial set-up, user and software licenses, maintenance)	Data transfer via internet (confidentiality, upload / down load capacity)
Scalable: ability to scale as business needs change	Data hosted at an external company (confidentiality)
No on-going system maintenance	Limited freedom for software configuration
	On-going costs for renting the system/service

Table 4: Outsourcing option: advantages and disadvantages

Advantages	Disadvantages
Speed: time from the decision to a pilot eCTD is very short	Dependency on an external partner for each project and throughout the life cycle of a submission
No initial investment and no reoccurring costs for system maintenance and technical support	On-going costs for each service during the whole lifecycle of a product/submission (initial submission(s), variations etc.)
No direct costs for software, licenses, hardware, system validation and maintenance, training	Data transfer (confidentiality, upload / down load capacity)
No need to establish, maintain technical knowledge in building and publishing eCTDs, no need for respective in-house resources (eCTD builder/publisher)	Data hosted at an external company (confidentiality)
Scalable: ability to scale as business needs change
Can also substantially-reduce risk of failed initial submissions

• There are 4 main scenarios that can drive the decision for outsourcing

1. there is no in-house software available to build / publish eCTDs or
2. the in-house capacities are too little
3. to gain experience for the creation of eCTD ready documents and eCTD submissions in-house
4. the number of eCTD submissions is too small, seldom use of the system

• Conclusion: The option with the lowest impact on processes and systems in a company is outsourcing. There are various different extents of outsourcing. Common to all is that the external partner will provide the necessary infrastructure / software as well as the personnel to prepare the eCTD.

Stay in connected with FWQRC™ for implementation of eCTD publishing & submission

USFDA Class I Recall,the most serious type of recall

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Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

• Medfusion® 4000 Syringe Pump with Firmware Version 1.7.0
• Model numbers 4000-0107-01 and 4000-0106-01
• Manufacturing Dates: June 25, 2019
• Distribution Dates: September 27, 2019 to October 31, 2019
• Devices Recalled in the U.S.:  627
• Date Initiated by Firm: October 28, 2019
• Device Use

The Smiths Medical ASD Medfusion 4000 Syringe Pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner.  Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for the adult population.

Reason for Recall

Smiths Medical has become aware of a software issue in the most recently updated Medfusion® 4000 Syringe Pump Firmware, Version 1.7.0, that could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death.

Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.

• Who May be Affected
• Healthcare providers using the Smiths Medical ASD, Inc.  Medfusion® 4000 Syringe Pump
• Patients who receive therapy delivered by the Smiths Medical ASD, Inc. Medfusion® 4000 Syringe Pump

What to Do

On October 28, 2019, Smiths Medical sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products.

The Recall Notice from Smiths Medical advised customers to:

• Locate all Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 in their possession. The firmware version of the pump can be identified by powering on the unit and observing the firmware version displayed on the screen.
• Determine the number of affected devices in their possession and complete the provided Recall Notice Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com even if they do not have any affected product in their possession. All affected product must be returned to Smiths Medical for processing.
• Upon returning the Response Form, Smiths Medical will provide a shipping label to return the affected product. Include a copy of the completed Response Form inside each box of returned product to facilitate processing. Ensure boxes are sealed and labeled with the facility name prior to shipping.
• If they distributed any of the potentially affected products identified in this Recall Notice, they should immediately notify the recipients of the potentially affected products by forwarding them a copy of this Recall Notice.

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Evaluation of Automatic Class III Designation (De Novo) Summaries

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Here we are going to discuss about the Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).

There are two options for De Novo classification for novel devices of low to moderate risk.

Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.

Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.

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FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

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Today’s review is about the recently launched application

The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH).

“The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms. When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs,” said Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner. “Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.”
The repository captures clinical outcomes when drugs are used for new indications, in new populations, in new doses or in new combinations. Health care professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient. The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions in the absence of established safe and effective options. Repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options.

“The potential importance of new therapeutic opportunities from repurposing drugs can’t be understated,” said NCATS Director Christopher P. Austin, M.D. “The CURE ID platform exemplifies how collaborative efforts can spark innovations that benefit patients. This new platform harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases.”

The app works by collecting a simple case report form from caregivers about their experience using an approved product for an unapproved use. Health care professionals can browse from a collection of cases that have already been documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally. The FDA plans to reach out to health care providers in various disciplines, including infectious and tropical diseases, to encourage them to use the app.
The full launch of the app follows the release of several pilot versions after an initial innovation award was received from the U.S. Department of Health & Human Services IDEA Lab in April 2015. During the pilots, extensive user-testing was conducted in India (2015 and 2017) and South Africa (2016). Additional feedback was also collected from users in the U.S., Europe and Peru. The updated app that launched today includes the addition of a newsfeed, an improved search feature with data from 325 different infectious diseases and syndromes to choose from, and the inclusion of nearly 1,500 initial cases from clinicians and the published literature and over 18,000 clinical trials.

To download and use the CURE ID application, visit https://cure.ncats.io or download “CURE ID” from the App or Play Store.

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