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Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 


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“Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine. The rise has more than doubled within three years of post-pandemic inspections. Figure 1 shows foreign and domestic inspections for all FDA-regulated categories: tobacco, devices, biologics, drugs, food, cosmetics, and veterinary. As inspections rise, organization are divesting their traditional quality departments, leaving major gaps in production operations and increasing risks within the business. Some of those include inadequate product investigation and root cause analysis; effectiveness checks not performed (leading to warning letters); and possible legal ramifications, such as injunctions.”


European Parliament committee adopts proposals to revamp pharma legislation

“The European Parliament’s health committee has voted in favor of proposals to overhaul pharmaceutical legislation, passing a raft of amendments to advance the lawmaking process to the next stage. Tuesday, members of the Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) met to vote on potential amendments to the European Commission’s proposals and on the overall texts. The politicians overwhelmingly voted in favor of changes to the current pharmaceutical directive and for the creation of a new regulation. Around 85% of votes were cast in favor of the proposals. Speaking during the vote, Tiemo Wölken, the ENVI rapporteur for the proposed regulations, said that “when we started this mandate, we didn’t know that we would be in the middle of the biggest health crisis in the European Union and the world so far.” The pandemic shaped Wölken’s goals for the proposal.”


FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity Guidance). FDA is proposing to add a Section VII. to the Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.” The Premarket Cybersecurity Guidance, in its current form, remains the agency’s current thinking until the new draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.”


How Will FDA’s New QMSR Affect Medical Device Companies?

“The idea of harmonizing FDA’s Quality System Regulation (QSR) with global standards is not a new one, said Vincent Cafiso, founder and managing consultant at Practical Compliance Results. He related that, in his opinion, FDA significantly revised 21 CFR Part 820 in 1996, which FDA based on the then current version of ISO 9001. “This actually showed some early signs of FDA’s intention to harmonize with some relevant global standard,” he explained. Meanwhile, ISO was also creating the medical device–specific ISO 13485 standard, based on ISO 9001. “So basically ISO 13485:1996 and the 1996 revision to the QSR started life around the same time and they both have the same parent, which was ISO 9001,” Cafiso said. “Those two ‘children’ have been serving the same purpose, just for different companies depending on where they do business in the world.”



Top 10 Takeaways from FDA’s Revised Quality System Requirements for Medical Devices 

“On February 2, 2024, the U.S. Food and Drug Administration (“FDA”) published a final rule1 to amend the current good manufacturing practice requirements for medical devices by harmonizing the existing requirements with ISO 13485:2016, the international consensus standard for device quality management systems used by regulatory authorities in many countries throughout the world. The revised requirements will be known as the Quality Management System Regulation (“QMSR”) … To reduce the regulatory burden on many global device manufacturers that must comply with both the QSR and ISO 13485, FDA is amending Part 820 to replace its QSR with the new QMSR that incorporates ISO 13485:2016 by reference. The QMSR also includes several additional definitions and requirements that clarify certain expectations and concepts from ISO 13485 and avoid potential inconsistencies with the FDCA and other applicable FDA requirements.”


FDA modernizing pharmacovigilance oversight with AI tools

“To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to support the review of adverse event reports and is also piloting the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to make it easier to use, said OSE Deputy Director Robert Ball. Speaking at DIA’s Global Pharmacovigilance and Risk Management Strategies Conference in Baltimore, MD, Ball said that OSE launched its Information Visualization Platform (InfoViP) an AI-based decision tool in 2022 to help the agency respond to the growing number of adverse event reports. The FDA receives more than 2 million reports a year, and this number is increasing every year. With these reports, FDA must decide whether to generate safety signals for marketed drugs.”



FDA Urges Independent Verification of Third-Party Testing Data

“FDA recently published a statement reminding medical device study sponsors and medical device manufacturers to evaluate third party’s contracted to conduct performance testing, urging independent verification of all testing results before submission to the agency. “It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate,” according to FDA.The agency said it has identified an increase in submissions containing unreliable data from third-party test labs, including numerous facilities in China and India. These third-party labs are reportedly creating fabricated, duplicated, or otherwise unreliable data for device submissions which, in-turn, has resulted in FDA’s inability to reach substantial equivalence determinations or authorize marketing for devices which include the data. Additionally, identifying the unreliable data could further call into question the entire files data integrity, the statement wrote.”


How Trailblazing Manufacturers Are Using Generative AI in 2024

“Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use. In 2024, manufacturers will increasingly apply it to their businesses and add it as a critical element in their digital toolboxes and as a powerful driver to their quality protocols. In fact, Gartner predicts that by 2026, more than 80% of enterprises will have used generative AI models and/or deployed them in production environments, up from less than 5% in early 2023.”



Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry

FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA’s current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.


Inside the FDA’s plans for the largest reorganization in its history

It’s been a tough couple of years at the Food and Drug Administration.Inspired in part by the tumult over the headline-generating infant formula crisis in 2022, the agency is planning to overhaul its structure to make its inspections more efficient and effective, officials announced last week. At an Alliance for a Stronger FDA webinar Friday, agency leaders — including principal deputy commissioner Janet Woodcock — unveiled the agency’s reorganization plan. The multi-pronged approach involves reforming not only its human foods program but also its Office of Regulatory Affairs (ORA) as a whole. “This is the largest reorganization in FDA’s history,” said Michael Rogers, the FDA associate commissioner for regulatory affairs. “There’s a level of excitement within the agency.” The reorganization will affect some 8,000 people at the FDA, Rogers said, calling it a “huge culture change.”



Warning letters: Same old, same old at FDA

Four warning letters posted earlier this year highlight that everything old is new again when it comes to enforcement problems for the US Food and Drug Administration. Specifically, FDA warned two companies for claiming their human cell and tissue products (HCT/P) can treat diseases or conditions without having an approved biologics license application (BLA), as seen in two recent warning letters. Additionally, the agency issued warning letters to two over-the-counter drug firms – one in the US and one in South Korea – for not testing incoming materials for contamination.
 FDA officials back in June 2021 said they were disappointed with the slow update of approvals of stem cell therapies and were stepping up their enforcement efforts against companies making unapproved therapies.

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5 FDA decisions to watch in the first quarter

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while the agency’s biologics division cleared 15 more. The clearances offer some counterbalance to a prolonged market downturn, during which the sector has struggled with a range of financial and regulatory headwinds.”




The Future of Industrial AI in Manufacturing: A Manufacturing in 2030 Report

​“The growing role and importance of artificial intelligence in manufacturing cannot be overestimated. This pervasive technology, now coming into its own after many years of development and trial and error, is being incorporated into many technologies involved in the manufacturing process, including semiconductors, software applications and platforms, and communications equipment. It is important for the manufacturing industry to understand how AI may shape how factories and plants are run in the years ahead, how it will influence workforce strategies, what business benefits may attend the use of AI and what challenges must be faced and overcome to realize the potential of this technology. At the highest level, a global competition for AI dominance is underway, with manufacturing as a key player in the race. ”


FDA to transition to electronic export documents for devices in 2024

“​Starting next year, the US Food and Drug Administration (FDA) will transition key export documents for medical devices from paper to digital format to reduce paperwork and streamline their workflow. Starting 2 January 2024, export documents for human medical devices that are regulated by the Center for Devices and Radiological Health (CDRH) will be issued electronically by FDA as downloadable PDFs from CDRH’s Export Certification Application and Tracking System (CECATS). The agency says the documents may then be validated by foreign governments and other entities who use the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Companies can access the FECV online database from a web address or a QR code on the certificate.”


medical device

In vitro diagnostic device regulation in Europe: Update on revisions

“The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework for in vitro diagnostic (IVD) medical devices to ensure their safety and quality. The enhanced regulatory framework to speed up the market release includes, but is not limited to, additional scrutiny by a notified body, risk classification and conformity assessment, vigilance and market surveillance, and performance evaluation and performance studies.”



Under a new law, FDA submissions must prove that medical devices meet cybersecurity standards

Already this year, major medtech makers including BDInsulet and Zoll Medical have all alerted their customers to cybersecurity vulnerabilities in their medical devices that could potentially compromise sensitive health information or other personal data. Hoping to prevent any such breaches is the FDA, which will now require medical device makers to submit information about their cybersecurity efforts alongside applications for regulatory clearance of their devices. The new requirements went live Wednesday, as a $1.7 trillion federal omnibus spending bill took effect, though the FDA said in an accompanying guidance that it doesn’t intend to begin enforcing them until Oct. 1, at which point device makers will “have had sufficient time” to adjust to the guidelines.


Combination Products Guidance

MDR transition delay approved by European Parliament and Council

“The European Parliament and Council today voted to approve a Medical Device Regulation (MDR) transition delay in an effort to avoid shortages. The move gives medical device manufacturers more time to certify their devices under the new MDR rules. I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food Safety Stella Kyriakides said. “This will help give clarity to manufacturers and ensure that patients can access the essential medical devices they need. This is our top priority. The delay does not modify MDR’s current safety and performance requirements. Instead, it gives manufacturers more time to move from the old rules to the new requirements. It also removes the “sell-off” date that would have prevented the sale of products already on the market but still in the supply chain and not yet received by the user before the transition period ends.”


Combination Products Guidance

FDA Wants More Diversity in Clinical Trials

“The U.S. Food and Drug Administration says companies that produce drugs and other medical products should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday. Though racial and ethnic minorities are affected disproportionately by certain diseases, they are frequently underrepresented in medical research, the FDA said in a news release. Barriers to participation include suspicion of doctors, religion, health illiteracy, and lack of understanding of clinical trials.”


The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR

“The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes,2 which is in its third edition since its 1996 release. The FDA QSR has not been updated since its 1996 release and needs to be brought to the current state of the art. Incidentally, the first edition of ISO 13485 was released at about the same time as the initial QSR, so 13485 has been updated twice while the FDA’s regulation has not been updated.”