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


House Floats Five Year Extension of Medical Device Tax

“The widely unpopular medical device excise tax would be delayed for another five years under a tax relief package introduced by the US House Ways and Means Committee on Monday. The 2.3% levy on the sale of prescribed medical devices was in effect between 2012 and 2014 after it was enacted through the Affordable Care Act in 2010, but the pushback from industry has led to several moratoriums. It received a 2-year delay extension earlier this year as part of a continuing resolution.”

Read the full article HERE!

pharmaceuticalStatement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

“Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety and preventing drug shortages of critical medicines. To meet these challenges, our policies and guidance must also evolve to ensure that quality standards are maintained, and to assist companies in building a culture of quality. To that end, one area we’ve focused new attention on in recent years is data integrity. Our goal is to ensure that the data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable.”

Read the full article HERE!

FDAFDA Issues Final Rule on Medical Device Classifications

“The U.S. Food and Drug Administration (FDA) has published a final rule that brings its medical device classification requirements in line with current medical device regulations. Published earlier this week in the Federal Register, the final rule, entitled “Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures,” updates and clarifies Part 860 (Medical Device Classification Procedures) of Title 21 of the Code of Federal Regulations so that they are consistent with the provisions of the FDA Safety and Innovation Act (FDASIA). The FDASIA came into effect in 2012 and established new processes for premarket approval (PMA) applications and for the classification and reclassification of medical devices.”

Read the full article HERE!

A ‘no deal’ Brexit could affect UK-EU pharma trade for six months, says UK gov’t

 By Flora Southey: Access to medicines across the English Channel could be ‘significantly’ reduced for up to six months, if the UK leaves the EU without a deal, according to MP.




Health Canada, the national public health department of the Government of Canada, has released a draft guidance document for manufacturers intending to license implantable 3D printed medical devices. The document states, “Due to the fast-changing technological environment, Health Canada will continue to adapt its policy approach to 3D-printing as issues on the topic evolve…” 


Draft Brexit Agreement’s Implications for Medical Device Sector

“The 585-page document outlines the UK’s transition from its current EU membership to full withdrawal. This transition starts on March 29, 2019 and ends on December 31, 2020. Article 127 on page 196 of the draft agreement clearly states that European Union Law will remain applicable during this transition period. This means that the placing on the market of medical devices may continue uninterrupted on both sides of the English Channel. It also means that Notified Body certificates will remain valid. It is not clear what will happen after that, because a new agreement must be drawn up regarding the relationship between the EU and the UK after the end of the transition period.”


The State of AI in Pharmaceutical Drug Development

“We both recently attended (and McCord spoke at) the AI Applications Summit for BioPharma, produced by Corey Lane Partners, LLC at Harvard Medical School in late October. We found the conference to be a very useful snapshot of what is happening at the intersection of AI and life sciences. We’ll describe ten of our observations…”


Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

“Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special “priority review” vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.”


FDAFDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk

“The Food and Drug Administration is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies. Since 1976, manufacturers have been able to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in when Congress established the pathway, known as 510(k). That means some new products entering the market are comparing themselves to technology that’s decades old. Now, the FDA wants to retire those predicates…”



pharmaceuticalTop current pharmaceutical outsourcing trends

“As time progresses and pharmaceutical companies are stretched for time, with limited expenses and also being short on resource, outsourcing seems the best way to control never-ending workloads. Whether the matter is running tests during clinical trials, arguing with insurance companies or facing continuous public backlash over rising drug prices, pharmaceutical companies are constantly challenged to work to high standards. “

Read the full article HERE!

FDACDRH FY 2019 Proposed Guidance Development and Retrospective Review

“For the Center for Devices and Radiological Health (CDRH), our guidance development processes are driven by our goal of helping to get safe and effective medical devices to market in a timely manner, and are informed by feedback from our customers, including patients, the medical community and industry. In today’s Federal Register, CDRH announced the list of guidance documents we intend to publish this fiscal year (FY2019). In addition, we committed to reviewing previously published final guidance documents, updating, or deleting guidance documents that no longer represent the agency’s current thinking on a regulatory issue.”

Read the full article HERE!

Pharma 4.0: Industry 4.0 Applied to Pharmaceutical Manufacturing

“The four evolutionary stages of manufacturing have brought us to Pharma 4.0.  The first stage comprised the implementation of steam power to mechanization. The second involved mass production, and the introduction of the assembly line, powered by electricity. The third stage added computers and automation into the mix, and the fourth is the introduction of cyber-physical systems that enable the computerization of manufacturing.”

Read the full article HERE!

CDRH Looks to Expand Case for Quality Program

“With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end.CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institute, CfQ program manager Cisco Vicenty said at a RAPS’ 2018 Convergence forum.”


Apple Watch received FDA clearance just one day before the launch; cardiologist questions ECG accuracy

“Apple made a big deal of the ECG functionality of the Apple Watch Series 4, and emphasized that the feature had received FDA clearance. It’s now being reported that the company was almost unable to do so – having received that clearance just one day before the launch event. But at least one academic wonders whether that clearance should have been granted in the first place. Venkatesh Murthy, a cardiologist at the University of Michigan, has questioned Apple’s claims for the accuracy of the ECG feature.”


FDADSCSA: FDA Finalizes 2 Guidances and Offers New Draft Q&A400

“With an aim to offer more guidance on the Drug Supply Chain and Security Act (DSCSA), the US Food and Drug Administration (FDA) on Wednesday finalized two guidances and drafted a question and answer document on product identifiers. The guidance follows FDA’s decision to delay by one year – until 26 November – its enforcement of the requirement for manufacturers to affix or imprint product identifiers.”


View the Draft Guidance Document directly HERE.

 By Ben Hargreave: With the US recognizing Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.


“In waves the US Food and Drug Administration (FDA) has been revealing the European Union (EU) countries that meet its good manufacturing practice (GMP) inspection standards. The mutual recognition agreement discussions between the US and EU had steadily moved closer to reaching a deal, with a series of smaller understandings, before the official announcement on Nov. 1, 2017, that the two countries would officially begin the process.”


Single-Touch Labeling: The Answer to EU MDR?

“The journey to adoption of Europe’s Medical Device Regulations (EU MDR) begins with understanding what’s changing—and when—and then establishing whether current systems and processes are sufficient to satisfy the new regulatory requirements. With the new rules mandating the redesign of every single label being used in supply to the EU market, it appears unlikely that medical device companies will be able to rely on long-term legacy labeling systems. However, with new regulations in other key markets also coming further down the line, organizations need to make sure that future systems have in-built agility to respond to change as and when it happens.”


FDA’s Strategic Policy Roadmap for 2018


FDA Commissioner Scott Gottlieb, MD laid out an 18-page “roadmap” for achieving the FDA’s 2018 goals and objectives. The broad sweep of initiatives addresses four main objectives: reducing opiod and other addictions, leveraging innovation and competition, empowering consumers and strengthening FDA’s scientific workforce.” 


Medical device sector sees most quarterly recalls in over a decade

Man looking at machine with clipboard“The second quarter of 2018 saw the largest number of medical device recalls during a single quarter since at least 2005, according to a recent analysis of U.S. recall data. Each quarter, product recall management company Stericycle Expert Solutions releases a “recall index” detailing the frequency and causes of U.S. product recalls in the food, pharmaceutical, automotive, medical device and consumer product industries. To compile its report on the second quarter of 2018, Stericycle Expert Solutions analyzed data from the Consumer Product Safety Commission, the FDA, the Food Safety and Inspection Service of the U.S. Department of Agriculture and the National Highway Traffic Safety Administration. The firm identified 360 recalls in the medical device sector during the second quarter of 2018, up 5 percent from the first quarter.”


Brexit and the pharmaceutical industry: what happens if there’s no deal?


The pharmaceutical industry has voiced its increasing concerns about the possibility of no-deal Brexit when the UK leaves the EU in March next year, and what effect this will have on the industry and the supply of medicines to patients. In response, the UK Government announced a range of advice on batch testing, safety and quality of blood and organ products, as well as the marketing authorisation of drugs and regulation of clinical trials.


Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for ManufacturersMedical Device

“The Food and Drug Administration’s (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the “Voluntary Malfunction Summary Reporting Program.” This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).”



FDA green-lights 14 digital health products, continues to evolve regulations


“…The FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the opioid epidemic, where developers could share their approaches to detecting, treating, and preventing addiction. The agency is also making some new moves when it comes to regulation. Notably, in June the agency ruled that genetic risk tests are officially exempt from requiring 510(K) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test.”


High-Risk Medical Device Approval Process in Europe Inches Towards Transparency

Man looking at machine with clipboard“The European Union (EU) is moving ahead with plans to provide better access to data surrounding the approval of implantable and high-risk medical devices, but a group of experts suggest that full transparency with respect to clinical and preclinical data, among other things, is the best path forward. In 2017, a new EU law was introduced that will eventually require manufacturers to provide a summary of the safety and clinical performance (SSCP) of high-risk medical devices. Prior to the regulation, the details of which are still being ironed out, the information that led to the approval of implantable, high-risk medical devices—drug-eluting stents, prosthetic heart valves, pacemakers, and the like—was confidential. Indeed, the first news a physician might hear about a new device was that it had been approved for use.”


CDER announces sweeping structural changes in letter from Woodcock to staff


Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, announced in-depth changes to the structure of the office this week in a note to staff. The changes will affect the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications. The aim of the changes, which are pending approval from the Department of Health and Human Services, and submission to Congress for concurrence, are “aimed at modernizing and strengthening the way FDA fulfills its public health and regulatory role,” according to Woodcock.


UK Votes to Stay in EMA

“The UK Parliament on Tuesday voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the island leaves the EU. The vote means Parliament will make it a negotiating objective for the UK government to seek the UK’s participation in the European medicines regulatory network, according to the UK BioIndustry Association (BIA). In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said: “Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.”