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Coalition for Epidemic Preparedness Innovations

The 2015-2016 Ebola epidemic and other outbreaks highlighted the need to better balance incentives for private R&D with coordination efforts to master emerging infectious disease (EID) crises. A new decision-analytic approach aims to move social bargaining processes closer to commitments for action.

CEPI members – including the three task teams and leadership group (see Annex 3 of the CEPI business plan, Coalition for Epidemic Preparedness Innovations 2016) – volunteered their time to engage in this exploratory decision-analytic process.

Vaccine Development

In the wake of the devastating Ebola epidemic, global thought leaders from governments, industry, and philanthropy agreed that new approaches are needed to speed up vaccine development. They launched an innovative international partnership — the Coalition for Epidemic Preparedness Innovations (CEPI) — to advance the development of medical countermeasures such as vaccines faster and ensure they are available to people during outbreaks.

CEPI aims to advance vaccine candidates through late preclinical studies through proof of concept and safety in humans. It will also establish vaccine manufacturing platforms that are flexible enough to respond quickly to outbreaks of unknown or emerging pathogens, called Disease X.

To do this, CEPI will work with low- and middle-income countries to build their capacities in vaccine testing, assay development, and other areas needed to support vaccine development. The coalition is based on the model of “networked multilateralism” that brings together partners for a limited amount of time to achieve specific goals – in this case, rapid vaccine development.

Vaccine Testing

Before vaccines can be tested in people, they go through preclinical tests with lab-grown cells and laboratory animals like mice or monkeys. This is to see if the vaccine might cause the right kind of defense response in humans and is safe enough to start testing with people.

Once a vaccine is ready for the human test, it goes through multiple phases of clinical trials with thousands of people to see if it works and is safe. The company making the vaccine must test every batch for quality, and FDA reviews the results and inspects the factories. There are also systems to track any possible side effects, like the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink.

The goal of this work is to reduce the time it takes for life-saving vaccines to be produced, delivered and distributed during epidemics and pandemics. This was a key theme of the summit, which was attended by leaders from governments, private philanthropy and industry.

Vaccine Stockpiling

In the wake of COVID-19 and EV71, it’s clear that emerging infectious diseases (EIDs) pose a serious threat to global health security. They not only kill millions of people but also cause immense economic disruption. This is why the world needs to better leverage vaccines to protect against EIDs – and that’s where the Coalition for Epidemic Preparedness Innovations can help.

The existing global vaccine emergency stockpiles managed by UNICEF are being stretched to their limits, particularly for the new EIDs being seen in Africa and beyond. Vaccine manufacturers are therefore working to improve their supply chain efficiency and one of the areas they are focusing on is vaccine stockpiling management.

This includes rethinking ways that vaccines are stored to ensure they can be shipped rapidly when needed. All held stocks are subject to risk of expiry unless specific contractual agreements mitigate this, and this adds up to substantial financial losses for manufacturers. Taking a more holistic view of vaccine stockpiling will require greater collaboration with buyers and the immunization community as a whole.

Vaccine Distribution

Vaccines are one of the most powerful tools available against epidemic infectious diseases, which can have devastating humanitarian and economic impacts. Yet, vaccine development can be a long and costly endeavor.

Creating a pipeline of vaccines for EIDs, increasing R&D response speeds to new disease threats, and improving equity through affordable pricing and regional R&D capability strengthening in countries most likely to experience epidemic outbreaks are all important priorities.

This year, CEPI is pursuing an ambitious agenda, which includes a “moonshot” objective to reduce vaccine development timelines to 100 days. The coalition is bringing together public, private and philanthropic organizations to support the development of platforms that can accelerate vaccine development against known diseases and unknown prototype pathogens that could lead to the next Disease X. This is an end-to-end approach to tackling emerging threats. This will ensure that the world has life-saving countermeasures available at a moment’s notice when they need it most. This will require unprecedented speed, coordination and innovation.

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Exploring the World of 안전사이트: A Guide to Safe Online Navigation

In the vast expanse of the internet, safety is paramount. Imagine stepping into a digital city where every street and alley promises adventure yet harbors potential risks. That’s where the concept of an 안전사이트, or “safe site,” becomes essential, providing a haven for internet users seeking to avoid the nefarious corners of the web.

What defines an 안전사이트? It is an online space that prioritizes user protection through stringent security measures. These measures thwart cyber threats, safeguarding personal information, and ensuring a secure browsing experience. A safe site operates much like a fortified castle, its walls shielded against digital marauders eager to breach its defenses.

Identifying a trusted 안전사이트 requires vigilance. Look for digital certificates and secure connections, symbolized by the lock icon before the website’s URL. Websites bearing the 안전사이트 mark of authenticity indicate a commitment to security, assuring users of their legitimacy. Trust is not given; it’s earned—safe sites understand this and work tirelessly to maintain a relationship of confidence with their visitors.

Cyber security isn’t just about fending off intruders; it’s about creating an ecosystem where users can roam freely and safely. The best 안전사이트 are those that not only protect but also empower their users with knowledge and tools to navigate the web confidently. From educational resources to real-time support, these platforms strive to keep their users informed and in control.

As we venture deeper into the digital age, the role of 안전사이트 grows increasingly critical. Innumerable dangers lurk behind seemingly innocuous links and downloads, and it’s these safe sites that stand as bulwarks against such threats.

In conclusion, the pursuit of a safe online experience is a collective endeavor. An 안전사이트 is not merely a refuge but a bastion of digital freedom. It allows us to explore, interact, and innovate without fear, secure in the knowledge that there are safe harbors amidst the chaotic seas of the internet.

FAQs:

1. What are the red flags indicating a website might not be safe?
– Discrepancies in the URL, lack of a secure connection indicator (HTTPS), misspellings or grammatical errors, and unsolicited download prompts are common red flags.

2. How do safe sites protect user data?
– Safe sites employ encryption, secure data storage practices, and regular security audits to protect user data.

3. Can an 안전사이트 guarantee complete safety?
– While no site can guarantee 100% safety, reputable safe sites significantly reduce risks by implementing best security practices.

4. What steps can users take to enhance their safety online?
– Users should employ strong, unique passwords, enable multi-factor authentication, and remain vigilant about the information they share online.

5. Are there tools that help identify 안전사이트?
– Yes, there are browser extensions, online security services, and verification tools designed to identify and validate safe sites.…

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In the vast expanse of the online world, there lies a hidden gem that promises not only entertainment but also security—a concept highly sought after yet often elusive in the digital playground. The 안전놀이터, or “safe playground,” stands as a beacon of trust for those seeking to immerse themselves in the joys of virtual play without the lingering fear of compromising personal safety.

Imagine stepping into a realm where the rules of the game are clear, where players contend on fair and equal grounds, where the adrenaline rush of competition is matched only by the assurance that your online presence is safeguarded. This is the essence of the 안전놀이터. Here, parents can breathe a sigh of relief, knowing their children frolic in a space that prioritizes their well-being. Gamers can engage with confidence, aware that their personal information is protected against the dark alleys of cyber threats.

What elevates the 안전놀이터 above the rest is a commitment to a secure framework, where rigorous checks and balances ensure that every swing, slide, and seesaw of the digital domain is scanned for potential hazards. Regular audits and updates are the norm here, making sure that the virtual grounds you tread are always up to snuff, always pristine in their promise of safety.

But how does an 안전놀이터 maintain its fortress-like integrity? Through state-of-the-art encryption technologies that shield data like a transparent, yet impenetrable dome. Through meticulously crafted privacy policies that treat user information with the utmost reverence. Through a community that watches over each other, where the safety of one is the concern of all.

As you navigate through the various attractions of the 안전놀이터, you’ll find yourself wrapped in the warmth of camaraderie, where every interaction is marked by respect and every transaction is smooth and secure. It’s a place where trust isn’t just expected; it’s woven into the very fabric of the experience.

In conclusion, the 안전놀이터 isn’t just a fleeting trend; it’s the future of online recreation. It stands as a testament to the fact that safety and fun can coexist harmoniously, and that the digital age can be a playground that welcomes everyone with open arms.

FAQs:

**What is an 안전놀이터?**
An 안전놀이터, or safe playground, refers to an online environment that is designed to be secure and trustworthy for users, offering them protection from potential cyber threats while they enjoy various activities.

**Why is safety important in online playgrounds?**
Safety is crucial in online playgrounds to protect users from scams, fraud, data breaches, cyberbullying, and other online risks that can compromise their personal information and general well-being.

**How do 안전놀이터 ensure the safety of their users?**
안전놀이터 typically employ advanced security measures such as encryption, strong privacy policies, and regular monitoring to protect users’ data and ensure fair and safe play.

**Can both adults and children use 안전놀이터?**
Yes, 안전놀이터 are designed for all ages, providing a secure environment where both children and adults can engage in online activities with peace of mind.

**Are there any specific regulations that 안전놀이터 must follow?**
안전놀이터 must adhere to various laws and regulations related to digital security, privacy, and consumer protection, which can vary by country or region.…

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8 Factor Analysis and Drug Abuse Potential

As drug prices increase, the Hatch-Waxman Actopens in new window is increasingly being seen as a barrier to affordable access to prescription medications. To overcome this hurdle, the law supports the development of generic drugs that are identical to brand-name drugs but cost less. A critical component of the process is an 8-Factor Analysis.

Factor 1: Abuse Potential

Abuse potential is a critical aspect of the US 8 factor analysis required by FDA and DEA for new drug development. Generally, the assessment is conducted as part of the overall safety evaluation and includes testing for the ability to induce a state of physical dependence and tolerance.

The types of abuse-related studies vary between drugs, but include functional behavioural observational studies, clinical drug-related AEs and human physical dependence studies. Sponsors are advised to discuss their planned abuse-related studies with CSS early in the process.

Factor 2: Risk of Abuse

Although not specified in the CSA, abuse potential evaluations (often called 8-factor analyses or 8FAs) must be conducted by FDA and DEA prior to scheduling new drugs, rescheduling them from one schedule to another, or removal from the CSA. In general, these 8FAs must include preclinical and clinical studies of the drug’s effects in animals and humans, with particular emphasis on overlapping effects with other known drugs of abuse. Functional behavioural observation and drug self-administration (drug discrimination) studies are typically employed in these evaluations.

Factor 3: Dependence

The CSA requires FDA and DEA to develop 8 factor analyses for new drugs approved by FDA, for rescheduling from one schedule to another, or for descheduling from the Schedule I list. While the CSA does not specify what types of studies and evidence are required in each of the factors, there is considerable variation in how 8FAs are performed in practice. For example, functional behavioural observation studies are often conducted in factor 1. Table 1 provides examples of the kinds of research commonly considered for each of the factors.

Factor 5: Potential for Misuse

In addition to a sponsor’s own abuse potential evaluation, the CSA requires a comprehensive abuse-related safety assessment (known as an 8-factor analysis) by FDA and NIDA for all new drugs approved by FDA and rescheduling or descheduling of already-approved substances. The FDA 8-factor analysis will cover a broad range of research methodologies from preclinical to clinical, including functional behavioural observation in animals and epidemiological surveys of real-world drug use patterns by the public.

These studies typically include preclinical models that assess the extent to which a drug is reinforcing and/or self-administration and human abuse potential assessments in comparison to known drugs of abuse. Other lines of evidence include chemistry, nonclinical in vitro and animal studies, physiological dependence and withdrawal, and a review of clinical trial adverse event reports.

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FDA-2018-D-3443 – Updated Guidance For Medical Devices With Cybersecurity Risks

The draft guidance updates the Agency’s 2014 final medical device cybersecurity guidance and encourages sponsors to take a total product lifecycle approach to security. It is also expected to improve premarket review efficiency and help ensure that marketed devices are protected against cybersecurity vulnerabilities.

Velentium’s Gates calls the new draft “a much better document” than the 2018 one that received substantial pushback from medtech manufacturers.

Software Bill of Materials (SBOM)

The FDA recommends that medical device manufacturers have a software bill of materials (SBOM) to identify and monitor cybersecurity vulnerabilities throughout the product life cycle. The SBOM should include all off-the-shelf, open source, and critical components used by a medical device.

This includes commercial software, third-party libraries, and custom-code. Larger medical device companies may have their own in-house programming talent, but smaller companies rely on the collective prowess of a potpourri of development firms to write the code for their devices and applications.

Many of these developers work on a freelance basis, and their contributions are often distributed across multiple projects. These projects could be in different programming languages and on various platforms, making them difficult to track. Furthermore, many of these components are constantly updated and patched, and it can be challenging to find the correct version of a component for a specific application. Consequently, a SBOM must be searchable to help customers quickly find the right version of a component.

Software Configuration Management

A software configuration management system (SCM) monitors the elements that make up software in order to keep track of any changes. The goal of SCM is to ensure that all elements of a software product remain up-to-date, available and functioning at the highest level possible.

A good SCM tool will help streamline team operations. For example, it can automatically record what parts of a software project are completed and where a team member is located. This helps to eliminate problems that may arise due to communication barriers caused by geographic or time zone differences.

SCMs also enable teams to work together more effectively, regardless of their location. This is especially important when working with off-the-shelf (OTS) software components that are being incorporated into a medical device product. This is because OTS software is often used by multiple health care facilities. The FDA recommends that sponsors provide the recommended documentation in a premarket submission for such OTS software, including clauses and subclauses based on the FDA-recognized version of ANSI/AAMI/IEC 62304:2006 & A1:2016, Medical device software – Software life cycle processes, including clause 5.1 (“Software development planning”), clause 6 (“Software maintenance process”), and clause 8 (“Software configuration management process”),54 among others.

Software Update and Patch Management

Patch management helps keep software, devices and systems up to date to prevent vulnerability attacks. It also improves performance and boosts productivity.

Security patches remediate specific vulnerabilities, which hackers often target. For example, the 2017 WannaCry ransomware attack spread over networks that didn’t apply a Microsoft patch to fix the flaw.

Testing patches before deployment is crucial to ensure that they don’t introduce any other problems (called software regressions). A centralized patch management server streamlines the process by automating all aspects of patch deployment, from identifying missing patches and checking their compatibility to operating system and third-party application components.

Effective patch management is essential for meeting industry security standards and staying compliant with regulations such as GLBA, HIPAA or PCI DSS. Failure to adhere to these standards can lead to fines, penalties and the reputational damage associated with data breaches. A proactive patch management program helps businesses avoid these risks. The FDA is working to establish standardization in this area, which should bring transparency to a patch management procedure that’s been historically fragmented and opaque.

Security Testing

The final guidance is a significant step forward from an earlier draft issued in 2018 that got pushback from stakeholders. The updated document lays out a total product lifecycle approach for medical devices with cybersecurity risks and provides recommendations for sponsors to include in premarket submissions.

The new guidance also recommends that manufacturers include information in premarket submissions about their software components and how the components can be updated or patched. This should bring more transparency to a process that has been idiosyncraticly tracked and not transparently shared across the industry, said Velentium’s Gates.

FDA is asking for SBOM to be in a format similar to the one that NTIA created as part of its multistakeholder process. It also suggests that sponsors use a tool to automate the production of machine-readable SBOM. The agency is being careful not to prescribe a specific vendor or tool for this purpose, Fu said. This is because NTIA’s effort to standardize SBOM formats and tools is ongoing.

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FDA-2018-D-3443 – Updated Guidance For Medical Devices With Cybersecurity Risks

The draft guidance updates the Agency’s 2014 final medical device cybersecurity guidance and encourages sponsors to take a total product lifecycle approach to security. It is also expected to improve premarket review efficiency and help ensure that marketed devices are protected against cybersecurity vulnerabilities.

Velentium’s Gates calls the new draft “a much better document” than the 2018 one that received substantial pushback from medtech manufacturers.

Software Bill of Materials (SBOM)

The FDA recommends that medical device manufacturers have a software bill of materials (SBOM) to identify and monitor cybersecurity vulnerabilities throughout the product life cycle. The SBOM should include all off-the-shelf, open source, and critical components used by a medical device.

This includes commercial software, third-party libraries, and custom-code. Larger medical device companies may have their own in-house programming talent, but smaller companies rely on the collective prowess of a potpourri of development firms to write the code for their devices and applications.

Many of these developers work on a freelance basis, and their contributions are often distributed across multiple projects. These projects could be in different programming languages and on various platforms, making them difficult to track. Furthermore, many of these components are constantly updated and patched, and it can be challenging to find the correct version of a component for a specific application. Consequently, a SBOM must be searchable to help customers quickly find the right version of a component.

Software Configuration Management

A software configuration management system (SCM) monitors the elements that make up software in order to keep track of any changes. The goal of SCM is to ensure that all elements of a software product remain up-to-date, available and functioning at the highest level possible.

A good SCM tool will help streamline team operations. For example, it can automatically record what parts of a software project are completed and where a team member is located. This helps to eliminate problems that may arise due to communication barriers caused by geographic or time zone differences.

SCMs also enable teams to work together more effectively, regardless of their location. This is especially important when working with off-the-shelf (OTS) software components that are being incorporated into a medical device product. This is because OTS software is often used by multiple health care facilities. The FDA recommends that sponsors provide the recommended documentation in a premarket submission for such OTS software, including clauses and subclauses based on the FDA-recognized version of ANSI/AAMI/IEC 62304:2006 & A1:2016, Medical device software – Software life cycle processes, including clause 5.1 (“Software development planning”), clause 6 (“Software maintenance process”), and clause 8 (“Software configuration management process”),54 among others.

Software Update and Patch Management

Patch management helps keep software, devices and systems up to date to prevent vulnerability attacks. It also improves performance and boosts productivity.

Security patches remediate specific vulnerabilities, which hackers often target. For example, the 2017 WannaCry ransomware attack spread over networks that didn’t apply a Microsoft patch to fix the flaw.

Testing patches before deployment is crucial to ensure that they don’t introduce any other problems (called software regressions). A centralized patch management server streamlines the process by automating all aspects of patch deployment, from identifying missing patches and checking their compatibility to operating system and third-party application components.

Effective patch management is essential for meeting industry security standards and staying compliant with regulations such as GLBA, HIPAA or PCI DSS. Failure to adhere to these standards can lead to fines, penalties and the reputational damage associated with data breaches. A proactive patch management program helps businesses avoid these risks. The FDA is working to establish standardization in this area, which should bring transparency to a patch management procedure that’s been historically fragmented and opaque.

Security Testing

The final guidance is a significant step forward from an earlier draft issued in 2018 that got pushback from stakeholders. The updated document lays out a total product lifecycle approach for medical devices with cybersecurity risks and provides recommendations for sponsors to include in premarket submissions.

The new guidance also recommends that manufacturers include information in premarket submissions about their software components and how the components can be updated or patched. This should bring more transparency to a process that has been idiosyncraticly tracked and not transparently shared across the industry, said Velentium’s Gates.

FDA is asking for SBOM to be in a format similar to the one that NTIA created as part of its multistakeholder process. It also suggests that sponsors use a tool to automate the production of machine-readable SBOM. The agency is being careful not to prescribe a specific vendor or tool for this purpose, Fu said. This is because NTIA’s effort to standardize SBOM formats and tools is ongoing.

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7 FDA Approved Food Dyeings That May Cause Health Concerns in Children

Artificial dyes, like the red tint in fruit punch and the green color in toothpaste, give thousands of foods their characteristic hue. But these chemical additives have been linked to health concerns in children. Several studies have linked them to hyperactivity and other neurobehavioral issues.

The FDA goes through a fairly rigorous process to approve food dyes for consumption. But are there alternatives?

1. Blue No. 1

Blue 1 is a synthetic dye, also known as Brilliant Blue FCF. It’s used in many foods including ice cream, tinned processed peas and candy. It is part of the triphenylmethane class of color additives.

Like other blue dyes, Blue 1 is poorly absorbed in the small intestine, and most of it is excreted unchanged in the stool. It has been permanently listed as a safe food dye under the Color Additive Amendments of 1960. However, it is not recommended for use in enteral tubes, due to its mitochondrial toxicity.

2. Green No. 3

Green dyes are the least used of all FDA-approved color additives. FD&C Green No. 3 is a synthetic triphenylmethane color derived by the oxidation of 2,2′-deethyl-bis(5-aminobenzenesulfonic acid) with either lead dioxide or dichromate. Animal studies show that only about 5% of the ingested dose is absorbed and excreted in the feces, but most is excreted unchanged (1).

Food safety experts are calling for a ban on all synthetic food dyes, particularly Red Dye No. 3, after a new report by the California Office of Environmental Health Hazard Assessment found that the dyes are linked to adverse neurobehavioral outcomes in kids, including inattentiveness and hyperactivity. Fortunately, there are natural alternatives to synthetic dyes.

3. Orange B

Orange B is an azo dye approved for coloring the casings of frankfurters and sausages. It is also used in a few foods, including maraschino cherries and cake icing. At high doses, this dye can cause liver and bile duct tumors in rats.

CSPI and other groups have asked FDA to remove this dye. A number of animal tests have suggested that it may cause cancer and neurotoxicity, and it causes allergy-like reactions in some people. It is also toxic to the environment.

4. Red No. 2

Red dye is used to make food products and medicine look more appealing. It is also used to indicate a specific flavor.

It is used in maraschino cherries, candies, powdered drinks, pet foods, bakery goods and ice cream. It can also be found in topical medications and some dietary supplements.

While there are many problems with most studies on these synthetic dyes, they do show that kids who consume these colors experience increased hyperactivity and irritability. That’s especially true for kids under the age of 2. The FDA has not banned this additive yet.

5. Yellow No. 5

This dye, more commonly known as tartrazine, is also used in paints and drugs. It provides a bright lemon-yellow color in many foods and drinks. It’s a popular choice because it’s cheap and stable.

Food processors use these dyes for a variety of reasons, including improving the shelf life of a product and homogenizing a beverage. However, they don’t add any nutritional value and there is emerging data that suggests that synthetic dyes are dangerous to our health.

Several studies have shown that eliminating foods with Yellow 5 in children improves ADHD, migraines, and other conditions such as bed-wetting and behavior problems. According to the Center for Science in the Public Interest, these improvements are based on objective measures and parent and teacher ratings after a four week dye elimination diet.

6. Yellow No. 6

Artificial dyes are petroleum-based chemicals that do not occur naturally. They are listed on food labels by their color and number, such as FD&C Yellow No. 6, or by their name, such as tartrazine.

Animal studies have shown that azo food dyes, such as Yellow No. 5, increase hyperactivity and irritability in some children. This effect is limited to a small percentage of children, however.

The International Association of Color Manufacturers says all colors approved by the FDA have been extensively studied. They are safe when used in moderation.

7. Red No. 3

The FDA banned Red Dye No. 3 in cosmetics and externally applied drugs based on studies that showed high doses can cause cancer in lab animals, but it’s still permitted in foods and oral medicines. That’s one of the reasons why CSPI joined with other consumer groups and scientists in submitting a petition to the FDA calling for its removal from foods, dietary supplements and oral medicines.

After the agency’s action on cosmetics, advocates expected that it would ban the dye in food, too. But thanks to some heavy lobbying by the maraschino cherry industry, that didn’t happen. Despite the health risks, it’s still used in thousands of brand-name and store-brand products, including Dole fruit cups, some varieties of Yoohoo and PediaSure and some brands of ice cream, according to a search of the Environmental Working Group’s Food Scores database.

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