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PATHWISE INDUSTRY NEWS

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

APRIL 2022 INDUSTRY NEWS

FDA

FDA issues MAPP on complex product classification for generic development

“The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are complex products for generic drug development purposes. MAPP 5240.10, published on 13 April 2022, provides definitions and examples of complex drugs and drug-device combination products, as well as the responsibilities and procedures for the OGD’s Complex Drug Working Group. The MAPP is part of FDA’s larger Drug Competition Action Plan, which has improving the efficiency of generic drug development as one of its core aims.”

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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​FDA Reissues 2018 Draft Guidance for Cybersecurity

“The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018. If enacted as a final guidance as written, investigational device exemptions would be within the scope of the FDA’s cybersecurity policies, one of the more significant changes found in the document. The FDA’s Center for Devices and Radiological Health released the draft April 7, stating that cybersecurity threats are both more numerous and potentially more clinically impactful. The draft places more emphasis on total product life cycle considerations, and the final version of this guidance will replace the previous final guidance of 2014. The fact that the FDA will take comment for 90 days, through July 7, 2022, is an indicator of the significance of the draft, given that many draft guidances are posted with only a 60-day comment period.”

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With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition

“The switch to a staggered implementation of IVDR has averted the prospect of the continued shortage of notified bodies disrupting the supply of tests in the European Union, but left other issues unresolved and in some cases amplified. Notably, with the EU pushing back the date on which many in vitro diagnostics companies need to fully comply with the new regulations, many more tests will be put on the market under the old directive than planned originally. It is unclear exactly how the EU will regulate these legacy devices. As the MDCG advisory group explained in its transition plan, IVDR states legacy devices are subject to the new requirements on “post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.” However, MDCG sees the wording as “rather general,” leading it to propose the creation of new guidance on legacy IVDR devices.”

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MARCH 2022 INDUSTRY NEWS

FDA

Be ‘recall ready’: FDA asks companies to take potentially harmful products off the market faster

“Though the FDA has the authority to call for a recall of any medical device or other regulated product that it deems a potential risk to public health, the agency is asking for assistance from manufacturers to get affected products off the market as quickly as possible.This month, the FDA finalized guidance outlining how makers of regulated products can become “recall ready” to minimize buyers’ and users’ exposure to any potential health risks. The guidance urges companies to prepare for recalls by installing a series of internal policies and procedures, and, once a recall is necessary, to move quickly in carrying out those procedures.”

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US replaces EU as priority market for medtech industry: survey

“The past few years have seen regulators on both sides of the Atlantic change their approach to medtech. The biggest changes have happened in the EU, where MDR and the In Vitro Diagnostic Regulation are redefining what it takes to bring products to market in the region. At the same time, FDA has set the target of making the U.S. the priority market for developers of novel devices.In its most recent assessment, FDA found almost two-third of manufacturers of novel technology devices plan to bring their products to the U.S. first or in parallel with other major markets.”

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EU GMP Annex 1 revision to be released mid-year

“The EU’s pending revision of Annex 1 covering good manufacturing practice (GMP) for sterile drug products is a “significant improvement” over the previous version and emphasizes the importance of risk management in preventing microbiological contamination of products, said Paul Gustafson, chair of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The final version also retains the controversial provision calling for testing filters in the cleanroom….Regulators in the EU drafted the revision, with input from PIC/S and the World Health Organization (WHO).”

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Quality metrics: FDA wants feedback on pared-down program

“The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry. The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016.”

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FEBRUARY 2022 INDUSTRY NEWS

FDA

Device Good Manufacturing Practice Advisory Committee Meeting Announcement

“The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee.  The committee reviews regulations proposed for promulgation regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs regarding the feasibility and reasonableness of those proposed regulations.  The meeting will be open to the public.”

READ THE FULL ANNOUNCEMENT HERE

Investigations

​FDA must shore up plans for surprise foreign inspections, rev up hiring of overseas investigators, GAO says

“Right after the FDA said it was resuming domestic drug inspections—with a view to rev up foreign inspections in April—the U.S. Government Accountability Office (GAO) said the regulator still has work to do to overhaul its oversight mission abroad.   To tackle three big hurdles facing its inspection work overseas, the FDA needs to develop “tailored strategies and time frames” to recruit investigators for its foreign inspection workforce, the GAO said Monday. Likewise, the regulator should adopt a pilot plan for unannounced foreign inspections and for the use of independent translation services abroad.”

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​FDA’s OPQ 2021 report focuses on pandemic responses

“Onsite inspections will remain the “irreplaceable standard” and are not going away anytime soon, despite the heavy reliance on remote tools to assess medicine manufacturing facilities during the coronavirus pandemic, officials from the US Food and Drug Administration noted in their 2021 report on the Office of Pharmaceutical Quality (OPQ). The 2021 report focused on the FDA’s actions in responding to the pandemic, as did the report from 2020… “As the world continues to navigate the effects of the continuing COVID-19 public health emergency, pharmaceutical quality is perhaps more important than ever before,” according to the report.”

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FDA’s Califf shares priority list with agency staff

“Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for Robert Califf as he retakes the helm of the US Food and Drug Administration (FDA). Califf’s priorities were outlined in a 17 February memo to FDA staff, as well as on his new official Twitter feed (@DrCaliff_FDA)…Califf said that he looks forward to “strengthening the FDA’s science foundation” and that one of his priorities is to counter misinformation about science. While not elaborating or pointing to real world examples, he may have been referring to the public’s misperception about the safety and effectiveness of COVID-19 vaccines and therapeutics.”

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JANUARY 2022 INDUSTRY NEWS

FDA

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

“Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, landmark program built on the premise that both sex and gender have a considerable impact on a woman’s overall health, not just their reproductive or sexual health. With patients at the heart of this initiative, and with the strategic plan as a blueprint for the center’s priorities, Health of Women intends to ensure all women have access to innovative, safe and effective medical devices.”

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pharmaceutical

5 industry execs discuss pandemic supply chain issues, solutions

“In discussing how the pharma industry has adjusted to the supply chain issues brought on by the coronavirus pandemic, Catalent president and chief operating officer Alessandro Maselli invoked the words of Winston Churchill. “Never let a good crisis go to waste,” Churchill famously said as he was helping form the United Nations following World War II. Judging from a recent Fierce JPM Week panel discussion, which included Maselli and four other industry executives, companies are definitely not letting this pandemic go to waste as they quickly adapt their strategies based on lessons learned over the last two years.”

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Accelerating Clinical Trials in the EU (ACT EU) initiative launch

“The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU). The Aim of Accelerating Clinical Trials in the EU (ACT EU) is to change how trials are initiated, designed and run to develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and better integrate clinical research in the European health system.”

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Califf previews priorities if confirmed as FDA commissioner

“In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket evidence generation… The two senators questioned Califf on a range of topics, including RWE, FDA’s accelerated pathways, digital health and software-based medical devices and the opioid epidemic. Focus obtained a copy of the questions, and Califf’s responses, from the Senators’ offices. “During my last tenure as Commissioner, I helped lead the agency forward toward more widely using real-world evidence in its regulatory decision-making processes.”

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Regulatory Requirements For A Clinical Investigation For Medical Devices According To MDR Annex XIV

“On May 26, 2021, the Regulation EU 745/2017 (MDR) entered into force after the Date of Application was postponed by one year due to the global COVID-19 pandemic. Per MDR Article 61.4, a clinical investigation shall be performed for novel implantable and Class III medical devices to demonstrate that the device is compliant with the general safety and performance requirements set out in Annex I of the MDR.”

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DECEMBER 2021 INDUSTRY NEWS

Quality Event Management

Pharmaceutical groups want more clarity on continuous manufacturing guideline

“Several industry trade associations are asking for more clarity on the International Council for Harmonisation’s (ICH) Q13 guideline on continuous manufacturing, including what constitutes a state of control for a continuous manufacturing process, the scope of the guideline, and the definition of a batch size. One manufacturer said the guideline places too much emphasis on non-conforming material, which has not been a significant issue in continuous manufacturing. The ICH Q13 guideline, released on 27 July, “describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).” The guideline covers continuous manufacturing of drug substances and drug products, including chemical entities and therapeutic proteins.”

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Investigations

Regulators recommend remote inspections for use post-pandemic

“A new review by a working group at the International Coalition of Medicines Regulatory Authorities (ICMRA), recommends the use of remote inspections as a complementary tool to on-site inspections beyond the COVID-19 pandemic. COVID-19 has necessitated a change to the world’s working habits, and pharmaceutical industry regulators are no exception. To maintain regulatory oversight of both good clinical practice (GCP) and good manufacturing practice (GMP) activities, regulators worldwide adopted remote assessments, using video conferencing software and devices to enable continuity of compliance oversight. Such technologies enabled the remote conduct of inspections, evaluations and assessments of certain activities and sites, even as the world was locked down with social distancing and travel restrictions.”

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pharmaceutical

Drug manufacturers and partners look toward advancements in post-COVID world

“With a global pandemic barely in the rearview mirror, the gaze of the pharmaceutical industry is clearly focused on what lies ahead. The tough lessons taught by COVID-19 have reshaped the global pharmaceutical supply chain and how manufacturers approach bringing new treatments to market. Pharma has also placed emphasis on coordination and communication with downstream stakeholders like distributors, payors, physicians, pharmacies and the ultimate end user—the patient. As much disruption as the crisis caused almost two years ago, the pandemic also heralded the introduction of new and innovative treatments, revealed the flexibility and strength of the global drug supply chain, and triggered widespread adoption of digital technologies that are here to stay.”

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FDA

Califf Garners Bipartisan Support During Senate Confirmation Hearing

“Republican senators appear poised to help confirm President Joe Biden’s pick to lead the Food and Drug Administration, even as some Democrats appear wary over what they see as repeated failures by the agency to rein in the opioid epidemic. Several Senate HELP Committee Republicans — including Sens. Richard Burr of North Carolina, Susan Collins of Maine, Tommy Tuberville of Alabama and Roger Marshall of Kansas — told POLITICO following Robert Califf’s confirmation hearing Tuesday they back returning the cardiologist to the commissioner post he held at the tail end of the Obama administration. Their support would likely push Califf through a committee vote and, later, a full Senate vote on the nomination.”

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NOVEMBER 2021 INDUSTRY NEWS

FDAFDA official: Growing number of enforcement actions stem from inspection alternatives

“Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections. So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October Pharmaceutical Quality Symposium sponsored by the CDER’s Small Business and Industry Assistance (SBIA).”

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More sites and sponsors betting on decentralized format: Science 37

 By Jenni Spinner

According to data released by the company, the majority of study professionals plan to run agile or hybrid trials over the course of the next 12 months.

HTTPS://WWW.OUTSOURCING-PHARMA.COM/ARTICLE/2021/11/17/MORE-SITES-AND-SPONSORS-BETTING-ON-DECENTRALIZED-SCIENCE-37 

5 things to know about FDA chief nominee Dr. Robert Califf

President Joe Biden on Nov. 12 nominated Robert Califf, MD, to lead the FDA, a highly anticipated announcement as Janet Woodcock, MD, has been serving as acting head of the agency for more than nine months.

 

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AION Labs Q&A: driving innovation in pharma AI

Last month, AION Labs, an innovation hub dedicated to encouraging new and innovative applications for artificial intelligence (AI) and computational science in drug discovery and development, announced its official launch. The Israel-based lab is an alliance between four major pharma companies – AstraZeneca, Merck, Pfizer and Teva – together with Amazon Web Services and the Israel Biotech Fund. This illustrious list of public and private partners have come together to create and invest in early-stage start-ups developing AI and computational solutions to challenges in the drug discovery and development space.

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