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

First FDA-approved vaccine for the prevention of Ebola virus disease

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The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.

Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD.

“While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.

“Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization.

These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.”

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Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….

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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