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PATHWISE INDUSTRY NEWS

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

SEPTEMBER 2022 INDUSTRY NEWS

Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

“Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel that are subject to live-streaming. While FDA has been conducting remote assessments since the start of the pandemic, its guidance, once finalized, would formalize its plan to use these assessments to supplement onsite inspections as it eases out of the pandemic response mode.”

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FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. The Annex has been revised to “reflect changes in regulatory and manufacturing environments. 

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FDA

FDA Lists Mechanisms to Comply With CGMP Requirements for Combination Products

“The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. The Annex has been revised to “reflect changes in regulatory and manufacturing environments.”

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Convergence: Experts see hope for meeting EU MDR deadlines

PHOENIX, AZ – With the European Union’s Medical Device Regulation (MDR) grace period ending in 2024, many medical device companies and consultants are nervous about what that means for their products, especially with limited notified body capacity. While some have fretted about getting new certificates of conformity under MDR in time for the 2024 deadline, experts on a panel on the topic at RAPS Convergence 2022 said there is light at the end of the tunnel. During 12 September session on MDR implementation, Gert Bos, CEO of Qserve and President of RAPS’ Board of Directors; Sabina Hoekstra-van den Bosch, regulatory strategy principal at TUV SUD and a RAPS board member; and Kevin Butcher, principal regulatory consultant at NAMSA; offered hope that sponsors will be able to meet their obligations in time.

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AUGUST 2022 INDUSTRY NEWS

EU issues long-awaited GMP Annex 1 revision

The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. The Annex has been revised to “reflect changes in regulatory and manufacturing environments. 

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pharmaceutical

Charging for expanded access drugs: FDA to let companies recoup their costs over time

The FDA on Monday updated guidance from 2016 on how companies can charge for investigational drugs under an IND, now telling sponsors working under expanded access that they can spread out their manufacturing, administrative or monitoring costs from the first year over the expected duration of the expanded IND or protocol. The shift may ease the immediate cost burden for some smaller sponsors that have expensive bills to recoup.

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Medical device industry poised to withstand an economic slowdown, experts say

While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession. Medical device companies are poised to weather an economic slowdown even as they continue to face hurdles linked to the pandemic such as persistent supply chain woes and staff shortages, analysts say. While device makers aren’t completely immune to potential recessionary pressures, the industry should be fairly resilient to a deepening downturn, according to Shagun Singh, an RBC Capital Markets analyst.

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MDCG posts guidance on notified bodies

The Medical Device Coordination Group (MDCG) has posted guidance on the designation, reassessment and notification of conformity assessment bodies and notified bodies. MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency and to align the working practices of the different designating authorities.” The first section of the guidance addresses the steps leading up to the inclusion of a notified body in the NANDO database, including pre-assessment and off-site activities, onsite assessment activities, post-onsite assessment activities and the decision on the designation. The second section covers the notification in NANDO, the objection period and the validity of the designation.

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JULY 2022 INDUSTRY NEWS

Bavarian Nordic receives European approval of vaccine label Imvanex

Bavarian Nordic has announced that the European Commission (EC) has extended the marketing authorization for the company’s smallpox vaccine, Imvanex. The treatment will also include protection from monkeypox and disease caused by vaccinia virus.The approval – which follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) – is valid in all EU Member States as well as in Iceland, Liechtenstein and Norway.

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FDA

FDA details plans to expand remote safety assessments for device makers

The FDA wants to keep and expand its ability to remotely conduct safety assessments even after the COVID-19 pandemic. The federal agency recently detailed its plans in new draft guidance for remote regulatory assessments (RRAs) covering all FDA-regulated products. FDA staff started conducting remote assessments when unable to travel due to COVID-19 restrictions, and regulators said RRAs will continue to be valuable beyond the pandemic. RRAs have been as simple as reviewing records, but also include voluntary interactive evaluations such as livestreaming video of operations, teleconferences and screen sharing.

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Supply chain disruptions: FDA guidance and temporary policies

The complexity of modern supply chains is never more evident than when disruptions demonstrate in real time how many interdependent processes and entities have to come together to deliver a finished product to the end consumer. Today’s consumers enjoy access to products made with components that can originate from multiple countries. A cheese pizza can be made with tomatoes grown in China, cheese from Italy, spices from India, and flour made from wheat grown and processed in the United States. This gives consumers access to a quality product comprised of the best, most cost-effective, globally sourced ingredients. However, this supply chain complexity has drawbacks, which have been amplified and highly evident during the pandemic. 

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Medtech firms warn Government of urgent need for action on EU certification process

A group representing Ireland’s medical device industry warned the Government that the implementation of new EU rules is running at under capacity. The EU’s Medical Device Regulation (MDR) came into application in May of last year and introduced stricter safety rules for medical devices. It requires device manufacturers to ensure new and existing products are certified under the updated rules. In a letter to Health Minister Stephen Donnelly, the Irish Medtech Association, part of Ibec, said “urgent action” is needed on a European level to prevent shortages of medical devices. 

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JUNE 2022 INDUSTRY NEWS

FDA

FDA’s QMSR: 3 Experts Read Draft Rule Comments So You Don’t Have To. Here’s What They Saw

“As of 25 May the US Food and Drug Administration has released online 50 stakeholder comments on its draft Quality Management System Regulation. When finalized, the QMSR will replace the agency’s aging Quality System Regulation (QSR). The QMSR is a result of the FDA’s years-long initiative to harmonize the QSR with international quality systems standard ISO 13485:2016. Longtime industry experts spoke with Medtech Insight on 25 May about comments they found particularly interesting or insightful. The experts include Kim Trautman, an ex-FDA official who was the lead author of the QSR in the 1990s; Steve Niedelman, lead quality systems and compliance consultant at the law firm King & Spalding, who worked at the FDA for 34 years in both the Office of Regulatory Affairs and the Center for Devices and Radiological Health; and Dennis Gucciardo, a partner at the law firm Morgan Lewis.”

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FDA’s Draft QMSR: 3 Experts Read More Stakeholder Comments So You Don’t Have To

“Industry experts recently spoke with Medtech Insight about comments they found particularly interesting or insightful. The experts include Vincent Cafiso, senior director of regulatory compliance & global audit at device maker Smith & Nephew; Kim Trautman, an ex-FDA official who was the lead author of the QSR in the 1990s; and Dennis Gucciardo, a partner at the law firm Morgan Lewis.This feature, which is the second of two parts, looks at comments from Microbiologics, Hamilton Medical and Philips.”

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pharmaceutical

Oversight from FDA at pharma manufacturing sites dipped during 2021 pandemic

The FDA completed less than half (48%) of its regulatory actions for pharma facilities designated as OAI or with an Official Action Indicated, within 6 months of an inspection closing, according to the latest report from the agency on the effects Covid-19 had on general oversight at manufacturing sites last year. The agency also lost pace in issuing final facility classification letters. In FY 2021, the report noted FDA issued 70% of final facility classification letters within 90 days of inspection closing. By comparison, in FY 2019, 87% of final facility classification letters were issued within 90 days of inspection closing, and completed 74% of regulatory actions for OAI facilities.

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Back to the drawing board for FDA’s revised quality metrics plan?

“The US Food and Drug Administration’s (FDA) revised plan to collect quality metrics data from manufacturers drew criticism from one major pharmaceutical industry group on the metrics the agency is proposing, as well as its methods for developing the program. Others complained that the proposed program lacks focus, while two industry groups also expressed serious misgivings about the purpose of the overall program. Yet on a positive note, one industry group and major manufacturer praised the plan’s flexibility in allowing manufacturers to decide which metrics to report. FDA issued the calls for comment in releasing its revised quality metrics proposal in March. The proposal is FDA’s attempt to revive its earlier stalled efforts to obtain manufacturing quality data to reduce potential drug shortages. The comments were a bit more supportive of the flexibility of this plan compared to previous iterations.”

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MAY 2022 INDUSTRY NEWS

FDA

US FDA moves forward with Voluntary Improvement Program to bolster medical device quality

“The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018. The FDA’s Center for Devices and Radiological Health (CDRH) released this draft guidance to describe its participation in the Voluntary Improvement Program (VIP). The VIP, facilitated through the MDIC, evaluates the capabilities and performance of a medical device manufacturer. The practices are appraised by third parties to promote process improvement and improve medical device quality. Based on the success of the pilot, the MDIC program activities and operations will transition into a permanent program…”

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The EU IVDR is here!

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland. The IVDR replaces the in vitro diagnostics Medical Devices Directive (IVDD). While the IVDR reinforces key elements of the previous regime, there are many important differences, in particular more rigorous rules on the classification of IVDs and the provisions governing performance evaluation and performance studies.

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FDA lays out framework for manufacturers and developers to tackle drug shortages

While the FDA says it has eased or thwarted “hundreds of new drug shortages” in the U.S. over the past 10 years, quality problems, global supply chain weaknesses, unexpected demand spikes, market withdrawals and natural disasters continue to threaten the nation’s stock of pharmaceuticals. To that end, the regulator unveiled new draft guidance Thursday to help manufacturers forge risk management plans aimed at combating drug shortages. Under the agency’s guidance, manufacturers of certain drugs and drug ingredients would be required to implement risk management plans. For others, the move is simply recommended.

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FDA and EMA mostly align on GCP inspection deficiencies, study finds

“A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.
The paper follows a mutual transatlantic cooperation on GCPs between the regulators that went into effect on 1 September 2009. Under the program, regulators agreed to collaborate on GCP inspections and share information on inspection planning and outcomes. This study compared decisions on 49 GCP inspections conducted by the two agencies related to clinical investigations submitted in marketing authorization packages between  2009 and 2015, and outlined the similarities and differences in findings for common inspection deficiencies.”

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