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


FDA’s New Efforts to Advance Biotechnology Innovation


“FDA is committed to helping ensure the safety of biotechnology products, while also facilitating innovation by applying a risk-based regulatory approach that provides developers with regulatory clarity and predictability and maintains public confidence in our regulatory system. And we’re taking some new steps to advance these goals. We know that products enabled by new techniques of biotechnology have the potential to significantly enhance public health.”


FDA Set to Propose Adoption of ISO 13485 for Quality Systems

ISO 13485“In an effort to harmonize its medical device quality management system regulations with globally-accepted standards, the U.S. Food and Drug Administration (FDA) is reportedly set to propose the adoption of ISO 13485:2016 as a replacement for its current Quality System Regulations (QSRs)…. “The proposed change is part of the federal government’s Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions,” and reflects efforts by the FDA to make it easier and more efficient for medical device manufacturers to sell their products outside of the U.S. while continuing to maintain high quality standards.”


Guidance for Pharmaceutical Companies to Prepare for UKs Withdrawal from EU

pharmaceutical“The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers document are marked ‘NEW’ and include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR).”


FDA To Issue Guidance on Cell and Gene Therapy in July

BIOLOGICS“Scott Gottlieb has kept himself busy during his tenure as head of the Food and Drug Administration. And the agency chief made clear in a fireside chat at the BIO International convention that the FDA has plenty coming down the pike in the months ahead — particularly in the areas of cell and gene therapy. Gottlieb pointed to the hundreds of Investigational New Drug applications currently in place for cell and gene therapies, citing one study that suggests as many as 40 of these drugs could be approved over the next few years.


FDA Withdraws Guidance on Biosimilar Analytical Studies

“In response to industry concerns, the US Food and Drug Administration (FDA) on Thursday announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic. FDA says it plans to reissue the draft guidance after considering changes to the document that will “promote a more efficient pathway for the development of biosimilar products…To date, FDA has approved 11 biosimilars to eight reference biologics since approving its first biosimilar in 2015. However, only a fraction of those biosimilars are available on the market, with legal challenges often adding years between approval and commercial launch.”



MDSAP Sees Site Participation Increase

Combination Products Guidance“Major changes are afoot at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and a number of voluntary pilot programs for industry will be key in determining the direction they are heading, officials said at the 2018 FDA/Xavier MedCon conference on Thursday. The Medical Device Single Audit Program (MDSAP) is among the voluntary programs that will help shape regulatory harmonization. Interest in the program, a pillar of the International Medical Device Regulators Forum (IMDRF), could benefit from more harmonization and has continued to gain momentum.”


FDA’s Medical Device Safety Action Plan

FDA“On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).”

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FDA Pilots New Site Selection Process for Inspections of Device Facilities

Investigations“The US Food and Drug Administration (FDA) is piloting a new statistics-based approach on the process for selecting device manufacturing facilities to conduct site inspections, agency officials told Focus. Developed at the Division of Biostatistics within FDA’s Center for Devices and Radiological Health (CDRH), a new software tool would transform the way agency staff are informed on where and how frequently to conduct site inspections through the Bioresearch Monitoring (BIMO) program. The pilot is part of ongoing efforts to extend FDA regulatory activities across the total product lifecycle. Adoption of the tool has the potential to improve FDA’s resource allocation—an issue underscored by recent legislative actions, such as the 21st Century Cures Act. This in turn could lead to significant time and cost savings for both the device industry and agency staff.”

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European and Indian Pharmacopoeias Coordinate on Quality Standards

“The European Directorate for the Quality of Medicines and Healthcare (EDQM), the European Pharmacopoeia Commission (Ph. Eur.), and the Indian Pharmacopoeia Commission (IPC) held a symposium on April 26 in Mumbai to discuss how the two pharmacopeias could work together to pool resources to improve quality standards for medicines and to harmonize activities. The IPC has had Observer status since 2016 and has participated in Ph. Eur. Commission working groups. The symposium was attended by authorities and manufacturers of APIs.”

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Greenlight Guru and PathWise Announces Joint Training Event in Switzerland

“PathWise is well respected in the medical device, pharmaceutical and biotech regulatory consulting and training industry,” says Greenlight Guru co-founder and CEO David DeRam. “This partnership will allow us to combine our purpose built quality management software platform with PathWise’s on-site training curriculum to serve a quickly developing market.” The relationship will consist ofon-site training to provide education and guidance on the rapidly evolving domestic European Union medical device regulatory environments, including MDR 2017/745 and the coming MDR 2020 implementation deadline. The training will be hosted in Basel, Switzerland June 27-29.”


A timeline to adopt medical device QMS (and why you need to act now)

“To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immediately. We’re in the window where there is less than a year until you need to be ISO 13485:2016 certified. There is no extension. ISO won’t accept any excuses – this has been published for at least two years now. I know you’re busy and there’s a lot going on, but I’ve heard some anecdotal evidence to suggest that perhaps as little as only 2 percent of US medical device companies have their certification done already. This came from an auditor at one of the largest notified bodies. That implies that a lot of companies are in the same position – they might be ISO certified right now, but they haven’t made the switch to get updated.”

Health Canada Eases Requirements for MDSAP Transition

“In response to medical device manufacturers facing audit scheduling challenges, Health Canada announced Friday a policy turnabout in requirements for transitioning to the Medical Device Single Audit Program (MDSAP).  Manufacturers will be required to submit MDSAP certificates by 31 December 2018 to legally sell devices in the Canada market. However, Health Canada has now decided not to take enforcement actions against manufacturers without these certificates if they demonstrate they have undergone a MDSAP audit by the same deadline.”

View the PathWise Webinar on the MDSAP program HERE!

FDA Medical Device Safety Action Plan Spotlights Cybersecurity

FDA“The Food and Drug Administration (FDA) released an 18-page document Tuesday designed to help protect patients from the risks of unsafe medical devices in an increasingly interconnected world. The document, titled “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,” outlines how the FDA intends to guard against current and future threats, both in the physical world and online. Like computers and the networks they operate in, medical devices can be vulnerable to security breaches. Exploitation of device vulnerabilities could threaten the health and safety of patients,” FDA Commissioner Scott Gottlieb said in a statement.”


12-month countdown: Industry raises ‘hard’ Brexit concerns

 By Flora Southe

With just one year to go until the UK withdraws from the EU, industry says regulatory repercussions for drugmakers are still unclear.