Data integrity issues are among the most significant compliance problems manufacturers struggle with today.
All too often, the scope of data integrity is misunderstood and oversimplified. Managing data and the systems that govern it stretch far beyond the IT department to encompass C-level executives and support groups in the areas of engineering, manufacturing, and quality. It requires a company-wide commitment to quality management that starts at the top.
This white paper offers a purely practical perspective on what data integrity is and how to mitigate data-related issues by developing and implementing a sound control framework. We'll also offer solutions to common data integrity problems.
To the FDA, suppliers and other third party vendors are an extension of your organization, making regulatory compliance your responsibility.
Outsourcing has become a global phenomenon among FDA-regulated manufacturers, making it absolutely critical to qualify new suppliers and manage quality on a routine basis.
This guide offers a step-by-step process for building better relationships with qualified suppliers and establishing a risk-based approach to supplier quality management. Inside, you'll find a summary of key regulatory requirements for supplier management, the formula for crafting an effective quality agreement and tips for working with third party professionals when planning and running supplier audits.
The regulatory environment is in a state of transition. New technologies, growing cost pressures and quickly-shifting consumer expectations are just a few of the factors driving changes in medical device manufacturing and regulatory compliance both domestic and abroad.
We've gathered the top FDA trends and developments for 2016 into this go-to guide along with advice from industry experts and on how these initiatives will affect medical device companies large and small.
We've included actionable summaries of the top ten FDA initiatives for medical device companies in 2016, key takeaways from recent FDA Guidance documents, and advice from expert consultants.
The regulatory environment is changing fast. New technologies, growing cost pressures and quickly-shifting consumer expectations are just a few of the factors driving changes in drug manufacturing and regulatory compliance both domestic and abroad.
We've gathered the top FDA trends and developments for 2016 into this go-to guide along with advice from industry experts and on how these initiatives will affect pharmaceutical companies large and small.
We've included actionable summaries of the top eight FDA initiatives for pharmaceuticals in 2016, key takeaways from recent FDA Guidance documents, and advice from expert consultants.
Receiving an FDA Warning Letter or Form 483 requires companies take immediate action to resolve issues and communicate those fixes to regulators within 15 business days.
Failing to respond or submitting an inadequate response can lead to enforcement actions that may threaten your ability to produce and market products.
This guide lays out the key steps to take after receiving an FDA Warning Letter or FDA 483 including the key elements of Corrective and Preventative Action Plans (CAPA), tips from experts on crafting an effective response, and how third party experts can help fill the gaps and assist you through the process.
As regulations tighten on the pharmaceutical industry, compliance issues pose a major threat to manufacturers throughout every FDA-regulated industry.
When issues do arise, it’s absolutely crucial to take action with a remediation project designed to identify and remedy the root causes of the problems at hand.
Our guide to remediation lays the groundwork for an effective remediation plan aimed specifically at addressing the root causes of compliance issues.
The standard, “ISO 13485:2003 – Medical devices – Quality management systems – Requirements for regulatory purposes”, specifies requirements for a quality management system for organizations that provide medical devices and related services. The standard outlines the requirements for a quality management system that meets both customer and regulatory requirements, applicable to the medical device industry.
On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for Laboratory Developed Tests (LDTs) based on risk on patients. This is a change from the current framework where regulatory oversight is determined based on whether the LDT is made by a conventional manufacturer or a single laboratory. FDA released the draft guidances describing the regulatory oversight for LDTs, which uses a risk-based approach and will be implemented over the course of multiple years.
The agency intends to enforce device registration and listing with the FDA for most LDTs. In addition, the agency will require the LDT manufacturers to submit adverse event reports to enable better post-market surveillance monitoring. For high and moderate risk LDTs, the FDA intends to have pre-market review and will enforce the quality system regulation, which affects design controls and the manufacturing of LDTs.
On April 13, 2015 FDA issued a Final Guidance Document titled, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. The original Draft Guidance was issued on April 23, 2014. The purpose of this guidance is to clarify FDA’s stance on balancing premarket and postmarket data collection during review of Premarket Approval Applications (PMAs).
This Guidance presents important insight for manufacturers with devices subject to PMA requirements. It includes details on both the benefits of using postmarket data and when postmarket data is appropriate from an FDA perspective. Leveraging postmarket data will result in decreased time to market and ensure continued surveillance of the safety of medical devices; therefore, the industry is encouraged to work with the agency to better understand the balance between pre- and postmarket data.
Virtually every device manufacturer that conducts studies on humans needs to determine whether an investigational device exemption (IDE) is necessary.
As such, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an IDE if it is needed.
While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program. There are many advantages to a MDSAP for both the medical device manufacturer and regulatory authorities.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP is still being evaluated to determine feasibility and the effectiveness of a single quality audit. When fully implemented, the MDSAP has the potential to greatly impact the medical device quality auditing environment.
On September 24, 2013, FDA issued a final rule on the Unique Device Identification (UDI) requirements for medical device manufacturers who market products in the US. While the regulation will require companies to implement many changes to current labeling, packaging, and quality system procedures, if strategically planned, a UDI implementation effort can result in improved product identification and tracking. Medical device manufacturers should fully understand the latest UDI regulations to facilitate the deployment of a compliant, cost-effective, and efficient UDI program.
FDA’s main motivation for developing the UDI regulation is to enhance patient safety. FDA suggests the UDI regulation will reduce medical errors, simplify the integration of device use information into data systems, provide more rapid identification of medical devices with adverse events, provide more rapid development of solutions to reported problems, and provide for more rapid, more efficient resolution of device recalls.
Social media has gained importance as a means of communication over the past several years. Sites such as Linked-in, Twitter, and Facebook have provided means for professionals and corporations to disseminate information faster than ever before. However, professionals in the pharmaceutical industry have been reluctant to use these outlets as a means of promoting products because of the Food and Drug Administration’s regulations regarding promotional materials. As such, the Food and Drug Administration has been taking steps to address these issues.
In addition to the regulations regarding promotional materials, a number of unique issues exist with respect to the use of social media. Some common issues include character limitations, incorrect information that has been disseminated by third parties, and accountability for information distributed via social media. As such, understanding these issues and how they affect the pharmaceutical industry is important.
With the progression of technology, it has become evident that there is a place for electronic documentation in clinical research. One area of particular benefit includes the informed consent process. Electronic informed consent (eIC) has the potential to offer great advantages over the traditional paper consent process.
If used correctly, eIC can serve as an effective tool for educating study subjects, managing informed consent records, and ensuring research participants are efficiently made aware of new information or study amendments.
Passed in July 2012, the Food and Drug Administration Safety and Innovation Act has notably changed the Food and Drug Administration’s authority regarding the collection of fees, the manner in which reviews of drug applications are conducted, access of patients to medications, and the participation of stakeholders in the process.
The legislation is expected to affect domestic and foreign manufacturers of pharmaceuticals, devices, and biologics considerably in the coming years. As such, pharmaceutical executives should understand the impact of this legislation.
The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.
Created in 1984, it is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference. A 505(b)(2) can been used to get approvals for changes such as New Delivery Mechanisms, New Dosage Forms, New Formulations and New Indications. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost.
As a result of a new regulation issued by the Food and Drug Administration, device manufacturers will be required to have a unique identifier for any device that they wish to market in the United States.
The law is already in effect for many Class III devices, and more devices will be required to have these identifiers over the next several years. Therefore, pharmaceutical executives should understand the new regulation and how to comply with it.
Three-dimensional printing is revolutionizing the way medical conditions are treated. These printers are able to create customized medical devices and other medical products for patients.
This new market is open to any manufacturer, not just medical device companies. Therefore, manufacturers should understand the trends associated with this growing use of technology.
To monitor public health more effectively, the United States government has issued regulations requiring organizations that manufacture and distribute devices to register with the Food and Drug Administration.
As such, any corporation or individual looking to market a device in the United States should understand the regulations and processes involved in registration.
To remain competitive, companies must be able to market the investigational products that they manufacture. However, no company can market an investigational product in the United States without approval from the Food and Drug Administration (FDA). New Drug Applications (NDAs) are one of the final steps that a company takes before a drug receives approval, and an overreaching goal for pharmaceutical manufacturers is to have their NDAs approved.
The consequences of a rejected NDA, such as decreased revenue, decreases in stock prices, and allocation of additional funds and resources to rectify the issue, are severe. Therefore, manufacturers should know what the process is, what the contents of an NDA are, and how to submit an NDA. They must also understand common issues associated with NDAs, reasons why NDAs are rejected, and ways to make the process run more smoothly.
An overall goal of pharmaceutical executives is to ensure that the products developed by their companies are approved by the appropriate agencies and marketed appropriately. However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency. At best, not following these regulations result in submissions not being approved or approval being delayed. This can lead to a loss of revenue and increased cost.At worst, not complying with the regulations can result in a company receiving warning letters and being subject to other disciplinary actions.
Given these issues, many pharmaceutical executives choose to enlist the expertise of a consulting firm that specializes in compliance with regulatory guidelines. These compliance firms provide a variety of regulatory services that enable executives to get pharmaceutical products on the market more quickly and to ensure that the appropriate regulations are followed.
Defects and performance failures in medical devices can seriously impact public health. To address these issues, a corporation may need to recall a device and correct the issues. Under ideal circumstances, a corporation identifies that a recall is necessary and initiates a recall. However, determining whether a recall is required is not always a straightforward process.
Because the Food and Drug Administration’s stance on the subject has been unclear, corporations may not know whether a change or defect is serious enough to warrant a recall. For instance, software upgrades are important to product safety and efficacy. However, because they do constitute a change to the product as marketed, pharmaceutical executives have questioned whether a recall is necessary. As such, pharmaceutical executives need to know when to recall a device as opposed to using another mechanism such as a market withdrawal or stock recovery.