Tag: fda emergency use authorization

Emergency Use Authorization (EUA) is a valuable asset that the FDA uses to make exceptions for unapproved medical devices during public health crises. It has brought up some controversy since COVID-19 started making its way around the globe. Regardless, there is little doubt that it has had a major impact on the regulatory policies of industries everywhere. EUAs are affecting more industries than just the medical device manufacturers. They’re also playing a role in speeding up approvals for other manufactured products.

 

Regulatory Impact of EUA Authority

 

Since just February 2020, the FDA has issued EUAs for more than 100 different elements, including drugs, devices and biologics. Other organizations, like those making personal protective equipment, ventilators and hand sanitizers, have gone through the EUA process for distribution approval.

 

At the beginning of the global pandemic, hand sanitizer started flying off of retail shelves due to the increase in COVID-19 fears. Doctors became desperate for PPE and respirators as patients entered hospitals in critical condition from the illness. Pharmaceutical manufacturers that produced these types of products wanted to make sure their goods reached the market faster. The quicker they were available for sale, the more patients and doctors could start reaping the medical benefits. As a result, it became more common to use EUA’s to skip over the lengthy 510(k) submission processes.

 

While this strategy can help manufacturers turn out new products more quickly, what happens after the emergency has passed? Vaccine acceptance rates in many countries are climbing.  If you work in our regulated industry, how will you keep products on the market over the long term?

 


Need help preparing your product for a EUA?  Contact RCA Now →


 

What You Need to Know About the Regulatory Impact

 

Receiving EUA approval provides a faster way for manufacturers to put their products on the shelves, even if those products are still in the experimental phase. The regulatory impact of EUA approval during COVID-19 is that more products are receiving fast approval than ever before. That said, it’s crucial to remember that this approval is only temporary.

 

The government needs to declare a state of defense or public health emergency before an EUA can be issued for a product. After the emergency passes, you’ll have to go through the regulatory approval process to ensure that your product is effective and safe to use. The COVID-19 vaccine has shown high efficacy and social distancing is becoming more relaxed. You need to consider long-term portfolio strategies so your product can continue its first-to-market advantage.

 

Preparation for an EUA submission into the market involves maintaining a consistent pharmaceutical supply chain flow. To have a product authorized, you may need to start gathering relevant information and resources. This can include test data, labeling requirements and clinical support. Going through the full approval process will ensure that your product is fit to serve the public on a long-term basis.

 

About RCA® Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

EUA consultingRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) spent more time than usual approving Emergency Use Authorization (EUA) authority for medical organizations. Fast-approving more than 100 medical device and testing kits in such a short amount of time is hardly standard practice for the FDA. Yet these FDA approvals during COVID-19 were essential to protecting public health and safety.

 

EUAs come with their own set of benefits and risks, as well as a detailed process to determine whether the devices in question are fit for use in emergency situations. As a result, it’s important to understand what this process is and how regulatory standards apply during unprecedented times.

 


Find out if a EUA is right for you.  Contact RCA Now →


 

FDA EUA

 

Emergency Use Authorization is a FDA program that allows health professionals to temporarily use an unapproved medication, medical device or medical procedure to save people’s lives. This law exists under section 564 of the Food, Drug and Cosmetic Act and is designed to protect medical patients with life-threatening illnesses who lack access to alternative treatment.

 

euaEUA authority is more common recently due to the widespread threat of COVID-19, which has infected millions of people worldwide. The FDA granted EUA approvals for a variety of items, including vaccines and new testing methods.

 

Regulatory & EUA Approval

 

Before a company can receive regulatory approval for a FDA EUA, certain criteria must be met. First, there needs to be a state of emergency, such as a threat to public health like COVID-19. The secretary of homeland security often makes this decision if there is a military threat, while the secretary of health and human services can declare a public health emergency.

 

Once the proper officials have declared a state of emergency, the FDA can decide whether or not to approve a drug, device or procedure based on:

 

  • The effectiveness of the unapproved product
  • The availability of alternatives
  • Risk to benefit analyses

 

For example, if a device is still being tested as a test kit for COVID-19 and it’s the only option to maintain supply, it can receive temporary approval from the FDA. This condition can apply if no other successful options are available. Most importantly, if product shortages are preventing care to patients in need.

 

EUA Benefits and Risks

 

The main benefit of an EUA is that it has the potential to save lives during public health emergencies by easing some of the restrictions under 510(k) submissions. It’s a temporary measure, giving health professionals the ability to administer unconventional treatment and go through the steps to have it long-term approved later.

 

Before approving a treatment for the EUA program, the FDA needs to conduct an analysis of the benefits and risks of Emergency Use Authorization. This process is challenging because of the discrepancies between cases. For example, one device might be in a different stage of approval than another. Subsequently, manufacturers may be sending in real time clinical data that varies based on similar devices.

 

Medical Supply Manufacturers

 

Weighing the positive effects of the device against the possible risks to patients can be difficult too. Healthcare manufacturers may be working with minimal or inconclusive data while seeking fast approval for their products. This situation puts heavy pressure on officials to make smart, informed decisions that will save as many people as possible.

 

The FDA is working to update and address new policies so manufacturers can continue to roll out life-saving assets. Some of the FDA guidance available are those that were left over after Ebola and the SARS epidemic years ago. For instance, the FDA offers guidance for absenteeism to account for people on sick leave. Guidelines also cover ways to handle social distancing while still adhering to regulations and maintaining productivity.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

euaRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue
Privacy Policy