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PATHWISE INDUSTRY NEWS

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

NOVEMBER 2020 INDUSTRY NEWS

 

Vulnerability of the medical product supply chain: the wake-up call of COVID-19

“The COVID-19 pandemic has brought the long-standing vulnerability of the medical product supply chain into sharp focus. Global shortages of medical products accompanied the global spread of the disease, joined by high prices, the proliferation of suspect dealers and dramatic interventions by governments, philanthropy and industry in oftentimes-unsuccessful attempts to secure solutions. Much attention has focused on personal protective equipment (PPE). But reported shortages have extended much further—to testing supplies, dialysis materials, pharmaceuticals and a wide range of commodities essential for daily care delivery—both for patients with and without COVID-19.1 2  PPE shortages have received particular attention because they endanger the healthcare workforce.3 But all product shortages endanger patients due to delays in care, rationing or denial of care, the use of substandard products, or heightened risk of error when using replacement products—risks that extend to increased mortality.”

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IMDRF Proposes Update on Post-Market Medical Device Studies

The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies. The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply to in vitro diagnostic devices. The proposal, which is open for consultation until 11 December 2020, was issued by the group’s Medical Devices Clinical Evaluation Working Group. “Complete characterization of all risks and potential benefits may not always be possible or practicable in the premarket phase. Therefore, there may be uncertainties (such as rare adverse events, potential benefits, long-term safety, clinical performance and/or effectiveness,) that should be addressed in the postmarket phase using one or more systematic postmarket clinical follow-up (PMCF) studies,.” 

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Building resilience into clinical trial design and conduct during the pandemic

“On 19 March, the MHRA first produced guidance for researchers on managing clinical trials of investigational medicinal products (IMPs) during the pandemic.  This guidance constituted details about a collection of established flexibilities and technologies that are available, but little used, despite their regulatory acceptance. The pandemic has required us all to adopt new ways of working and many trial sponsors have taken advantage of the available flexibilities to support the safe initiation and ongoing conduct of trials in both COVID-19 and non-COVID-19 indications. We have now published updated guidance and are encouraging trial sponsors to embed these flexibilities into their business-as-usual activities, where appropriate, in order to build resilience into new and ongoing trials during the continuing pandemic.”\

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MDSAP council updates guidance on conformity assessments and related requirements

“Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical device manufacturers. The MDSAP Council also added annexes providing further details and guidance on assessing conformity for each audited process; giving deadlines for submitting adverse events reports and advisory notices; and outlining requirements for written agreements between manufacturers and suppliers, with references to key clauses from international medical device quality management standard ISO 13485:2016.”

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OCTOBER 2020 INDUSTRY NEWS

FDA

With new guidance, FDA moves toward uniform postmarketing reporting

“A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information. The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of postmarketing requirements (PMRs) and postmarketing clinical trials (PMCs) if required to do so under section 506B of the Federal Food, Drug, and Cosmetics act (FD&C Act), or if PMCs are agreed upon by applicants and FDA.”

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Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry

“This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.”

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New online platform for scientific advice

“From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice At any stage of a medicine’s development, the developer can ask for guidance and direction from EMA, known as scientific advice, on the best methods and study designs to generate robust data on how well a medicine works and how safe it is…The IRIS platform will provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.

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Investigations

USFDA inspections taking longer time than usual due to COVID-19 safety protocols

“US drug regulator, Food and Drugs Administration (USFDA), took almost a month to complete the inspection of the facility of Sun Pharma’s New Jersey subsidiary Ohm Laboratories early this year. The Ohm Laboratories plant makes prescription and OTC drugs in solid dosage forms. The USFDA also took almost a month to complete an inspection of oral solid manufacturing facility at Dayton, New Jersey of AuroLife, a wholly owned subsidiary of Aurobindo Pharma. Both inspections were conducted during January – February this year.The inspection of Lupin’s Somerset facility in New Jersey, which began on September 17, is still under way.”

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A Culture of Responsibility: Laboratory Safety at the FDA

A cornerstone of the U.S. Food and Drug Administration’s scientific work is to ensure that we operate our laboratories in a safe and secure manner. October 2020 is the seventh anniversary of Biosafety & Biosecurity Month, an initiative begun at NIH to raise awareness and improve the effectiveness of biosafety programs nationwide. This year’s theme is The Role of Biosafety and Biosecurity in Mitigating Emerging Risk, and the Association for Biosafety and BiosecurityExternal Link Disclaimer is focusing activities on identifying best practices and lessons learned from the COVID-19 pandemic. As a nation, we have made significant changes to minimize the risks of the current international public health crisis, one that has profoundly upended our professional and personal lives. “

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SEPTEMBER 2020 INDUSTRY NEWS

 

Regulatory obligations beyond the new MDR deadline: A long-term focus

“Even with the EU MDR transition deadline being pushed back one year until May 2021, the deadline is still fast approaching. Many organizations were stretched thin in their attempt to meet the changes to the vast number of Standards and regulations for the original deadline. While achieving compliance before the new deadline is essential, many companies within the medical device (MedDev) industry may find themselves in trouble in the months following. Keeping on top of your regulatory obligations and staying compliant should be a long-term focus. Just as MedDev organizations have devoted specific resources and time into a strategy to meet the short-term deadline of EU MDR, organizations should also prioritize a long-term strategy of maintaining compliance. Meeting these requirements should be a strategy that is “always on”, not intermittent.”

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UK regulation of medical devices from 1 January 2021

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published new guidance (the “Guidance”) on how medical devices will be regulated in Great Britain (“GB”) (England, Wales and Scotland) and in Northern Ireland following the expiry of the Brexit transition period under the EU-UK Withdrawal Agreement on 31 December 2020.The Guidance is of relevance to all medical device companies operating or selling devices in the UK. It retains many of the elements of the MHRA’s previous “no-deal” Brexit guidance but differs in certain respects, including setting a clear timeline for a new UK medical device regulation framework from July 2023. The UK left the EU on 31 January 2020 and existing EU medical device legislation has continued to apply in the UK under the terms of the EU-UK Withdrawal Agreement during the Brexit transition period. When that period expires on 31 December 2020, existing EU legislation will be automatically incorporated into UK domestic legislation to the extent possible.

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FDA

The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

“The U.S. Food and Drug Administration’s mission is to protect and promote the public health, both in the U.S. and globally, by ensuring the safety and effectiveness of the products we regulate. Nowhere is this public health mission more evident than in the FDA’s role in the scientific and regulatory oversight of vaccines. One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines. Why are vaccines so critical to helping end this pandemic? Vaccines are one of the most significant public health interventions ever implemented. They have been largely responsible for the dramatic reduction in serious adverse consequences and death related to infectious diseases such as smallpox, polio, and measles.”

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Drugmakers get return-to-normal guidance from FDA

“A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic. This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply,” said FDA in announcing the availability of the temporary guidance.”

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AUGUST 2020 INDUSTRY NEWS

 

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

“The availability of notified bodies designated under MDR has remained a worry despite the decision to delay implementation of the regulation until next year. Travel restrictions imposed to curb the spread of COVID-19 stopped notified bodies from performing on-site audits of device manufacturers, leading MedTech Europe to call for authorities to permit remote assessments for incoming regulations. DQS has been taking advantage of the option to perform remote audits under the existing Medical Device Directive. The remote audits enabled the notified body to maintain device certifications while the German government had travel warnings in place.”

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Petri Dish

CBER Takes On More Oversight Of Biologic & Biosimilar Master Files

“The Drug Master File (DMF) is one of the most effective ways for companies to protect proprietary information while still collaborating with partners. A DMF is a snapshot of the manufacturing process that is submitted to the FDA to review the suitability of a drug for clinical trials (INDs) or commercialization (NDAs or BLAs). When a DMF is submitted to the FDA, its contents are confidential. The proprietary information may only be cross-referenced — not accessed — by a partner. Under this model, the company that cross-references another company’s DMF is not expected to understand and/or be able to defend the partner’s process and process controls. This year saw a significant change in the process for submitting master files for biologic products: as of March 23, 2020, biologic-related master files are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER).”

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MDCG explains how notified bodies can use MDSAP audit reports

“In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR). While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used to inform the scope and focus of surveillance audits performed by notified bodies. It is important to stress that the MDR/IVDR remain applicable in their entirety. The use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements,” MDCG writes.”

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FDA

FDA delays collecting drugmaker data required by CARES Act

“The FDA said this week that it won’t begin collecting new data required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act next month, though the measure is set to take effect Sept. 23, Regulatory Focus reported. Though the rule is set to take effect next month, the FDA says the electronic data submission portal it’s developing for drugmakers to submit the information won’t be ready by then. FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues,” the FDA said.”

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COVID-19 Medical Device Shortages and What the Industry Is Doing About It

“Medtech has really stepped up this year to respond to medical device shortages brought on by the COVID-19 pandemic. Despite these impressive efforts, there remains a growing list of medical device shortages. FDA maintains a publicly-available, up-to-date list of the medical device shortages tied to the pandemic. This list is part of FDA’s obligation under the CARES Act, which was signed into law on March 27. Of the 20 products that FDA listed on Friday, eight are categorized as testing supplies and equipment, nine are considered personal protective equipment, and three are ventilation-related products.”

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