FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017

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The Food and Drug Administration (FDA) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.

Read the final ruling here.

Pharmaceutical and Medical Device Recalls – Statistics and Facts (Statista.Com)

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A product recall occurs when safety issues or defects in a product are found that might endanger consumers, or put the producer or seller at risk of legal action. When this happens, the product is taken off the market resulting in financial loss for the producing company and potential damage to the company’s reputation.

Product recalls in the pharmaceutical industry are not rare. For example, in the first quarter of 2018, 84 companies in the U.S. reported at least one recall. For pharmaceutical companies, the cost of the actual recall is not the most costly aspect of recalls. Around half of pharmaceutical product recall costs result from the subsequent interruption to business that the recall causes. 

Similarly, medical devices are also regularly recalled, with the main cause of recalls involving software and quality issues. In FY 2017 alone, the FDA inspected 2,652 establishments where medical devices were manufactured, processed, packed, installed, used, implanted or where records of results from use of such devices were kept. Furthermore, the FDA issues Warning Letters to companies concerning medical devices and potential problems associated with them. 

Read more about this topic on Statista.Com.

FDA’s New Data Integrity Guidance — Highlights & Observations

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The scope of the FDA document includes drugs, biologics, and positron emission tomography drugs. The agency also states the requirements are consistent with the requirements in ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, thus expanding the scope of the document to APIs and drug substances. The FDA states it is the “role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value. …”

Read more here.

FDA Clarifies Human Subjects Protection Expectations

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A new guidance from the U.S. Food and Drug Administration (FDA) provides welcome direction to sponsors, investigators, and institutional review boards (IRBs) on human subjects protection.

The guidance is one of the agency’s follow-ups to its revisions of the “Common Rule” (Federal Policy for the Protection of Human Research Subjects), which became effective in July 2018. General compliance for the revised Common Rule is mandated to begin in January 2019. The purposes of the Common Rule are to promote “uniformity, understanding, and compliance with human subject protections and to create a uniform body of regulations across federal departments and agencies,” FDA explains in the new guidance.

The requirements contain several new areas of informed consent, including changes relating to the content, organization, and presentation included in the consent form. It also clarifies the process to facilitate a prospective subject’s decision about whether to participate in research. FDA is clarifying the provisions to help sponsors and investigators develop, and IRBs implement, two separate informed consent forms.

The guidance also follows up on earlier FDA rules which allowed IRBs to use expedited review procedures for certain kinds of research involving “no more than minimal risk.” The new guidance includes a list of categories that may qualify for the fast track, while it also makes clear that, as appropriate, IRB reviewers must find that the research on the list involved no more than minimal risk.

The Link Between Quality Metrics, Data Integrity, and Quality Culture

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Data Integrity continues to be one of the hottest topics in our industry and for very good reason. Without the necessary systems and/or processes in place to ensure data integrity throughout the product lifecycle, product quality and patient safety issues are more difficult to detect and therefore mitigate in a timely fashion.

It is important to understand what data integrity really means in order to be compliant. Essentially, it refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.

Quality metrics, quality culture, and data integrity are of particular concern to both the industry and regulatory authorities. Pharmaceutical Online has published an interesting history of how these three areas have come together in establishing current global regulatory expectations.

Read the article here.

API Development: 5 Critical Mistakes to Avoid

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API

Less than ten percent of drug development programs successfully reach the commercial marketplace. Most organizations strive to produce as many effective compounds as possible to increase the chances of commercialization. In order to avoid major challenges later during commercial scale-up, personnel from Development, Manufacturing, Quality Control and Quality Assurance should be aware of critical mistakes that can occur during the early development phase.

Learn more about these challenges from this article at Pharmaceutical Online.

August 10, 2018 FDA Warning Letter to Kyowa Hakko Bio Co., Ltd.: Failure to ensure the API manufactured at the above-mentioned facility are in compliance with CGMP

MDSAP: Are You Ready?

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MDSAP-Prepare-the-transition

ISO 13485:2016 is the internationally agreed upon standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. This standard will be fully implemented by 2019. New rules and revisions to existing requirements apply throughout the QMS, especially for those organizations managing vast networks of suppliers and vendors. Key areas/processes impacted are document control/management, change management, supply chain, and product lifecycle. Additionally, device usability and post-market surveillance requirements will all be affected.

Learn more from the resources below:

Looking for more support and guidance with respect to MDSAP inspection readiness? Contact MWA today.

The Drug Supply Chain Security Act: Is Your Supply Chain Secure?

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Supply Chain

Managing the Drug Supply Chain is complex and challenging for any organization. Risks associated with supply disruptions and drug shortages have the potential to impact patient’s lives. With the introduction of the Drug Supply Chain Security Act (DSCSA), all players within the pharmaceutical industry are confronting the challenge of implementing a serialized drug tracing system with little guidance on data standards, roles, or accountabilities.

“The Drug Supply Chain Security Act (DSCSA) is a federal standard that “outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States,” according to FDA.

“The DSCSA is more than a rule… It is a global mandate, requiring any company wishing to sell a pharmaceutical product in the U.S.A. to facilitate product ‘traceability’ by 2023. In theory, this means a consumer should be able to pick up a bottle at a pharmacy and see all the hands that touched it prior to the point of sale.”

Read more about the three distinct stages of implementation (Product verification, Serialization, and Traceability).