Tag: FDA Approval

Food And Drug Administration

Posted on by Brandon Miller

The Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, recently testified in front of a Senate Appropriations subcommittee about core programs for the 2025 budget process. Executives at FDA are asking for a $341 million increase in the annual budget (currently proposed at $7.22 billion) compared to the previously approved FY 2024 budget.

 

Drug Shortage

 

One topic that received significant interest was drug shortages. Dr. Califf confirmed there are still over 200 drugs classified as in shortage. FDA has requested over $12 million to help rectify the problem and bring greater predictability to supply chain problems. Additionally, the ability to clarify pharmaceutical manufacturing problems that may arise appears to be a priority to FDA.

 

Regulatory Affairs

 

The Office of Regulatory Affairs (FDA ORA) has asked for an additional $2.7 million to be added to the proposed budget. Specifically, ten new full-time employees are proposed as headcount to address issues with both drug shortages and problems inside the supply chain. $3 million is specifically proposed to recruit new FDA inspection resources who can help identify these types of scenarios in advance during routine FDA inspections.

 

Further, continued growth in regulatory applications for both medical device manufacturing and biologic manufacturing facilities was mentioned as critical to keep pace with the industry’s need for FDA approval inspections. For life science industry employees, the slowdown in FDA inspections has had mixed reactions.

 

Michael Rogers, associate commissioner for regulatory affairs at the FDA’s Office of Regulatory Affairs, has also recently commented about the need for more FDA auditors due to investigators who have recently retired. According to Rogers, FDA investigators “have been underrecognized and underappreciated”, which may have led to attrition over time at the agency.

 

Avian Influenza Virus

 

Dr. Califf continued the discussion with lawmakers about the potential dangers of avian influenza (or bird flu) and vaccine production. Commentary revolved around how prepared the United States government is in responding to virus mutations if bird flu could spread to humans. Further, Dr. Califf elaborated on how investments in personal protective equipment (PPE) & funding for vaccine manufacturing could help the potential problem.

 

Finally, short-term solutions focused on the safety of dairy workers if the virus infected the U.S. milk supply, and new research options to study how quickly the avian influenza virus may evolve. 

 

IT Infrastructure

 

Finally, FDA has requested over $8 million to improve critical infrastructure and upgrade technology across the agency. The goal is to modernize many of the legacy workflows the regulatory agency uses and increase the analytical potential of data analysis.

 

The entire presentation can be found at this link. 

 

Pharmaceutical Consultant & Pharma 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 the 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

 

food and drug administrationRegulatory 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. 

 

Clinical Trials FDA Guidance

Posted on by Brandon Miller

The FDA recently updated guidance for clinical trials & trial design. This update stems from an objective of the 21st Century Cures Act (Cures Act). It includes recommendations for how industry sponsors of pharmaceuticals or biologics should design and conduct clinical trials. The guidance provides a greater explanation of how biologic and oncology trial design can simultaneously evaluate more than one investigational drug.

 

FDA Guidance

 

The guidance goes into depth about the clinical research milestones of master protocol design. Data integrity considerations are also mentioned for biomarker co-development and trial statistical analysis. Traditionally, oncology clinical trials are designed to assess multiple investigational drugs at the same time. Clinical data in this type of design is analyzed across multiple cancer types during the same trial to find all sources of patient efficacy and commercial value.

 

Another primary driver is the CDMO race due to testing multiple drugs and sub-populations under the same protocol. Pharmaceutical consultants like RCA Inc. have witnessed a shortening of client commercialization timelines across the life sciences industry. This directly adds incremental pressure on project sponsors. Clinical teams are being tasked to discover late-stage drug success faster than ever before. Every trial must simultaneously ensure patient safety while producing data that satisfies the regulatory safety and effectiveness.

 

Need help with your Clinical Trials? Talk to our Experts. 

 

Investigational Drugs (IND FDA)

 

The FDA concisely describes this unique protocol design and clinical trial planning for IND filings and multiple sub-studies. Sub-studies may have separate goals and require aligned efforts across the data science team. For example, collaboration is needed in order to appropriately value multiple investigational drugs. Consideration should be given that therapeutic value may be in one or more disease sub-types in the clinical trial.

 

With these considerations in mind, the FDA goes on to describe the benefits of a master protocol across the study design. This provides the project sponsor design flexibility via electronic data capture (EDC) in an EDC system (e.g. shared control arm, adaptive designs, centralized data capture).

 

Clinical Trial Design

 

This new FDA guidance also provides insights on potential challenges the industry should consider when using master protocols. These unintended consequences can include greater difficulty when assigning detailed adverse events to an investigational drug if numerous products are being investigated across the clinical study.

 

Any lack of adverse event reporting clarity can impact the safety profile of an investigational drug. This directly makes the clinical analysis for FDA approval more complicated for the regulatory body. Multiple study groups can also increase the overinterpretation of study findings. For example, signs of positive product efficacy for cardiac biomarkers could be different than from cancer biomarkers. Biomarker discovery for one subpopulation could also be identified as false if based a different ad hoc patient group.

 

Basket Trials

 

Basket trial design includes assessing an investigational drug blend by including a dose-finding or safety lead-in component. The goal is to identify safe quantities of the combination early in the clinical trial before progressing with an efficacy activity-estimating factor. The FDA proposes therapeutic efficacy for sub-studies within basket trials are constructed as single-arm, activity-estimating trial. The primary endpoint would be recorded as total response rate.

 

The guidance goes on to elaborate on sub-study objectives, including study rationale for each population. A comprehensive statistical analysis plan (SAP) with reasoning for sample size and unique stopping rules based on ineffectuality should also be included in the program documentation.

 

Umbrella Trials

 

A master protocol designed to evaluate multiple drugs is commonly referred to as an umbrella trial. These umbrella trials are often administered as a single drug or as a combination product. Umbrella trials are often a randomized controlled trial to evaluate the mechanism of action of the investigational drug/drugs with a common control arm. Study design for an umbrella trial can include sub-studies based on a patient biomarker or to a separate therapeutic sub-study inside the trial.

 

Clinical Study Design

 

As the clinical study focus, the FDA provides a clear understanding of how project sponsors improve the efficiency of master protocols. For example, using a common control arm during an Umbrella Trial has proven to help evaluate multiple drugs simultaneously for a single disease state.

 

Control Arm

 

For clinical trials, the FDA now recommends a project sponsor use a common control arm when numerous drugs are evaluated simultaneously in a single illness (e.g. umbrella trials). The FDA guidance elaborates in the use of a control arm be the current standard of care (SOC) so trial results are understandable from the perspective of the biologic and oncology medical community.

 

Changes in SOC can also take place during the trial because of an FDA approval or the latest scientific data. The Statistical Analysis Plan (SAP) would need to be revised before any data analysis occurs if this is the case.

 

Novel Drugs

 

When a project sponsor uses sub-studies to assess two or more investigational drugs, the FDA advocates for providing a thorough scientific motivation for the combination. This includes the clinical trial sponsor defining the Recommended Phase 2 Dose (RP2D). Analysis should include each novel drug and ensuring the appropriate dosage has been identified for each individual drug.

 

Targeting Biomarkers

 

The FDA goes on to elaborate on digital biomarkers to help validate the patient selection and recruiting for clinical trials. Biomarkers should be clearly identified based on the intended therapeutic response.

 

For example, an oncology biomarker for tumor size can help predict the response to the investigational drug. This type of study biomarker might demonstrate how the mechanism of action succeeded or failed. There needs to be a consensus among the clinical study team on how biomarkers are justified. Understanding study measures for showing marker positivity before patients enter the trial is critical.

 

Data Monitoring

 

One final important note about the master protocol in the updated FDA guidance describes the independent radiologic review committee. This committee medical research should include blinded tumor-based assessments to provide a charter for the independent data monitoring committee (IDMC).

 

The IDMC charter would guide the committee through ad hoc trials, such as patient efficacy and drug futility. The IDMC can also recommend clinical trial protocol actions. This often includes changes in sample size or modification of a sub-study based on overwhelming futility or efficacy evidence.

 

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

 

Clinical TrialsRegulatory 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. 

Medical Device Testing

Posted on by Brandon Miller

In the world of medical device testing, manufacturers should seek to identify key characteristics that set a high-quality laboratory aside from the rest. A successful medical device testing relationship should be built on trust, quality, and integrity. Some potential consequences for choosing an incapable third-party testing partner include inaccurate results, legal liability, regulatory compliance issues, wasted resources, and more. Most importantly, failure to achieve FDA approval or regulatory approval can lead to timely delays, wasted products, and the loss of business opportunities. 

 

How to identify a medical device testing partner

 

While the cost of medical device testing is often a determining factor, it’s essential to consider the cost of quality when selecting a testing partner. Additionally, assessing the laboratory’s ability to deliver testing results within required timelines without compromising quality is an advantage. It is critical not to be misled into unrealistic turnaround times or lower costs that could lead to re-testing and/or delays due to unreliable data driven by a lack of competence in testing. High-quality reliable data you can trust comes with appropriate timelines required to support critical sample preparation, strict quality control measures, and complex analysis.

 

In addition to cost and turnaround time, be sure to look for the following criteria when choosing a medical device testing laboratory to support your products:

 

A strong quality system

 

Quality management systems (QMS) are essential to ensure the reliability of all aspects of testing. From safeguarding the accuracy and confidence of results to the implementation of quality control measures, a strong QMS contributes to greater trust in 3rd party testing. One that has been regularly audited by the FDA is favorable.

 

Actively participates in standard development

 

Continued involvement at industry meetings including standard development keeps testing laboratories at the forefront of regulatory science and enables them to help you make the right testing decisions that are compliant and widely accepted. Technical expertise and experience go a long way in the proper support and understanding of the ever-evolving world of standards.

 

Upholds proper accreditation (ISO 17025)

 

The first sign of technical competence is accreditation to ISO 17025 which specifies the general requirements to carry out tests and/or calibrations, including sampling. Compliance with the FDA’s ASCA program is also desirable in addition to other industry-specific organizations. Accreditation demonstrates 3rd party testing compliance with international standards and ensures the credibility of lab testing services.

 

Robust regulatory resources

 

Internal subject matter experts who understand the complexities of globally regulated manufacturers will lead to more successful testing outcomes. Selecting a third-party laboratory that offers in-house expertise in this area can help reduce the regulatory feedback burden.

 

Customer-driven

 

Reliable and accurate medical device testing results are essential for maintaining customer satisfaction. Since a test report is often the final product provided by a testing laboratory, the overall customer success should be highlighted as critical to the overall success of the laboratory.

 

By specifically evaluating these factors, you can identify a strong third party testing partner that meets your specific testing needs and standards of quality, reliability, and competence.

 

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. You may also email us at [email protected].