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PATHWISE INDUSTRY NEWS

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

JANUARY 2023 LIFE SCIENCE NEWS

FDA

FDA Will No Longer Require Animal Tests Before Human Trials for All Drugs

“Animal testing will no longer be a mandated part of the Food and Drug Administration’s approval process for all new drugs. Since 1938, pharmaceutical makers seeking FDA approval have had to successfully put their medications through multiple animals trials before proceeding to human tests. Now, though, drug companies will have the option of either animal or non-animal tests—in a shift that animal rights groups and some pharma companies have long advocated for. Meanwhile, researchers’ reactions are mixed: Some say the move is unlikely to trigger immediate change, others are excited by the possibilities, while others still have safety concerns.”

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​EU commission moves forward with proposal to delay MDR implementation

“Medical devicemakers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses. The European Commission adopted a proposal Friday to delay the full implementation of the new Medical Device Regulation, or MDR. According to the commission’s announcement, the proposal will now be sent to the EU’s parliament and council, where final approval is set to arrive through an “accelerated co-decision procedure.”Stella Kyriakides, the EU’s health commissioner, proposed the delay last month as complaints about stricter regulations and the high costs and long waits to comply with them reached a fever pitch.”

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ICH adopts Q9 guidelines on quality risk management

“The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages. The ICH Q9(R1) guideline was published on 20 January, and updates the original guideline, which is now 18 years old. It covers the principles of QRM, the general QRM process, risk management methodology, the integration of QRM into industry and regulatory operations. It also has two annexes addressing QRM methods and tools and another on potential applications for QRM.”

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FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses

The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first two immunizations with the new bivalent omicron shots. If the FDA accepts the advisors’ recommendation, the U.S. would likely phase out the companies’ vaccines developed in 2020 against the original Covid-19 strain that emerged in Wuhan, China.”

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INDUSTRY NEWS 2022- OUR TOP STORIES!!

QMSR: FDA proposes QSR overhaul after years of delays

“Four years after the US Food and Drug Administration (FDA) signaled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016, the agency on Tuesday issued a proposed rule laying out its vision for the long-awaited regulatory overhaul. The resulting regulation would be dubbed the Quality Management System Regulation (QMSR). According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards. FDA is also proposing to give device makers one year from the publication of the final rule to adapt to the new regulatory requirements.”

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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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Investigations

FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections

“A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools. Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program division director, Division of Pharmaceutical Quality Operations III, Office of Regulatory Affairs…”

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UK medical devices law reforms delayed till 2024

“The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimise the risk of supply disruptions for UK patients. The delay means manufacturers whose medical devices have a ‘CE’ marking, which certifies their compliance with EU medical device regulations, will be able to continue placing their devices on the Great Britain market up until 30 June 2024, not 30 June 2023 as previously indicated by the UK government.”

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Investigations

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.”

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Combination Products Guidance

FDA Lists Mechanisms to Comply With CGMP Requirements for Combination Products

“As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration is finalizing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. While the FDA has provided examples in this notice of the types of mechanisms that may be appropriate, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process. and CP manufacturer.”

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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.”

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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.”

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DECEMBER 2022 INDUSTRY NEWS

FDA official pushes for cloud-based regulatory assessments

“A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions. Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research, and other agency officials discussed efforts to modernize the regulatory submission process. Yu is also the rapporteur of the International Council of Harmonisation’s (ICH) M4Q(R2) expert working group tasked with modernizing quality information that is submitted in the common technical document (CTD).”

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Surgery in Space: NASA tests advanced medical technology for the Moon and beyond

University of Louisville, Orbital Medicine, and Purdue University researchers have been developing technology that is intended to regulate and restrict bleeding and ease surgery in space. The Flight Opportunities program at NASA is helping to advance the innovation of space-based medical advancements, according to an updated press release by the U.S. Space Agency on Tuesday. “Conducting surgery in space is not something we’ve had to contend with yet, but the further we travel from Earth, the more likely it is that we will need expanded medical capabilities,” said George Pantalos, Ph.D., principal investigator for the Surgical Fluid Management System (SFMS) at the University of Louisville. “And because of the microgravity environment, surgery and wound care in space will be very challenging.”

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Biopharma trends leaders should consider for 2023

Healthcare is constantly evolving based upon technological advances, available data, and social trends. The primary goal of biopharma leaders is to ensure that life-changing medical treatments are developed and manufactured, with a sharpened focus on reducing the time and cost associated with bringing new drugs to the market. However, as the industry shifts, biopharma companies must find ways to balance their goals while simultaneously shifting patient needs to stay relevant and afloat.

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FDA’s Califf talks with Focus about 2023 priorities

“It’s been almost a year since Robert Califf returned to the helm at the US Food and Drug Administration. The commissioner talked to Focus about his unfinished work, his hopes and concerns for the future, and more in a year-end review.
 Focus: When you stepped into the commissioner’s office again, what unfinished business did you want to prioritize from your previous tenure at the agency? 
 Califf: There was a long list of things that I thought could be made better. I think a lot of them have to do with supporting the internal workings of the agency, the employees and the systems in which they work, hiring the right people, and improving their ability to get their work done through better information technology. Those were internal things that I think people tend to undervalue that pay off in many, many ways for all the many areas in which the FDA works. “

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NOVEMBER 2022 INDUSTRY NEWS

Europe faces 2024 bottleneck in device reapprovals as submissions slow

“Changes to the MDR timeline mitigated the threat of immediate disruption to device supply, although it left the industry facing a bottleneck in 2024. To quantify the backlog, the European Commission surveyed the notified bodies designated under the directives. The survey showed that there were 22,793 valid directive certificates as of October, down from 24,073 in April. Most,  or 17,095, of the certificates are set to expire in 2024. If companies wait until close to the deadline to seek MDR certification, demand may overwhelm notified body capacity and leave applicants without the paperwork they need to continue selling their devices after May 2024.”

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Industry asks FDA to align quantitative labeling guidance with other regulators

“Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators. The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of sodium, potassium and phosphates. In the draft guidance, FDA wrote that quantifying these constituents would help health care providers manage their patients’ total daily intake when treating conditions such as heart failure, hypertension or chronic kidney disease.”

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Covid-19 spurred a historic vaccine R&D effort. What does it mean for future pandemics?

“In the historic campaign to vaccinate the world against Covid-19, Corbevax was far from the first vaccine to reach the market. While the first mRNA shot became available 326 days after the SARS-CoV-2 virus was sequenced, the journey of Corbevax — which has so far gone into the arms of 75 million kids in India and recently won approval for adults — spanned about 600 days. But Peter Hotez, one of its co-inventors, believes it could’ve played out differently if his team had received more funding and there was a smoother regulatory path. “That could have been probably cut in half had we had the support to move faster,” said Hotez, the co-director of the Texas Children’s Hospital Center for Vaccine Development.”

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OCTOBER 2022 INDUSTRY NEWS

FDA

FDA finalizes guidances on device post-approval studies, postmarket surveillance

“The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and to better understand the agency’s expectations for conducting post-approval studies of these products.The final versions contain minor changes from the draft versions released for comment in May 2021. “These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling postmarket surveillance requirements and of Post-Approval Studies (PAS), respectively.”

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New EU data quality framework aims to align stakeholders

​”The European Medicines Agency (EMA) on Monday published a data quality (DQ) framework intended to put stakeholders on the same page regarding data quality, as data has become more critical to regulating medical products. The joint Big Data Steering Group, created by EMA and the Heads of Medicines Agencies (HMA), has published a document titled, Data Quality Framework for EU medicines regulation. It lists definitions, principles and guidelines that stakeholders can apply to a wide range of data sources to characterize and assess data quality used for regulatory decision-making. EMA says that the progress in digitization and information technology, and the resulting plethora of data being generated in health care creates opportunities for regulators but also makes for an increasingly complex landscape for regulatory decision-making. The agency hopes to use the framework to get everyone involved to agree on definitions and terminologies to ensure high quality of the data that it uses when regulating products.”

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FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

“The FDA published 13 of the 23 guidance documents planned for 2022, with most, 10, coming from the A-list. Still, the lighter publishing schedule compared to last year, when the FDA proposed 10 draft guidance documents on its A-list, means most of the top priorities in 2023 are left over from 2022.In the coming fiscal year, the regulator plans to publish draft guidance on voluntary malfunction summary reporting, clinical considerations for medical device premarket submissions targeting opioid use disorder and select updates for guidance for the breakthrough devices program. All three proposals also featured on the FDA’s A-list for 2022. The only newly proposed draft guidance on the A-list covers an electronic submission template for de novo request submissions.”

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Experts Still Concerned About Exceptions Under DSCSA

“Throughout HDA’s Traceability Seminar in Washington D.C. today, experts expressed concerns over undecided exception management processes that could lead to pharmaceutical products in limbo and disrupted supply chains under the Drug Supply Chain Security Act (DSCSA). There are a number of ways that operations can go awry as saleable units, aggregated cases, and their associated data move through the supply chain. Often receiving top billing in industry conversations: “Product, no data” exceptions. As the name implies, this scenario occurs when a trading partner receives a product shipment without data. It may mean that the majority of the shipment and data match, and maybe a single case’s data is missing, or it could be a larger volume issue where an entire truckload (or more) arrives without corresponding data.”

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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

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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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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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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