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



China’s FDA releases revised medical device classifications

medical deviceLate last month, the Chinese Food and Drug Administration announced a number of changes to medical device classifications, revising criteria and categories and reducing the risk level of 40 different categories of products, according to China Med Device.  In the update, the CFDA added more than 5,000 product name examples, bringing the total up to 6,609 from the original 1,008 devices in the 2002 catalogue, according to the report.

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FDA Requests Input on Reducing Regulations

FDA“In response to Presidential Executive Orders aimed at reducing regulatory burdens, the U.S. Food and Drug Administration (FDA) is seeking comments to help the Agency “identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.”

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FDA Drafts Guidance on Post-approval Manufacturing Changes for Biologics

BIOLOGICSAs the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. “Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report,” the agency says (italics are FDA’s).”

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“Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress

Drugs“Today, a new and exciting technology – continuous manufacturing (CM) – can truly transform the drug manufacturing process so that it is more reliable and efficient. We discussed in a previous blog how CM enables a much faster and more reliable manufacturing process. In some cases, manufacturing that takes a month to complete with older technology — often called “batch” technology — might only take days using CM. FDA is seeking input, through a public docket open until September 21, from experts in the field about the science, technology, and best practices concerning CM.”

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FDA quality pilot aims to streamline device review process

The FDA is piloting a new scheme for high-risk medical devices that removes the need for preapproval inspections in return for making more information on device quality available early on. The aim is to target the regulator’s premarket approval and post-marketing inspections more effectively, and “promote quality in device design and manufacturing,” which in turn should reduce device failures and recalls, says the agency in a Federal Register post. The Premarket Approval Application Critical to Quality (PMA CtQ) pilot is looking for nine device manufacturers willing to collaborate with FDA on identifying the characteristics of a device that are most important for the quality of the product as well as the process used to manufacture it.”

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Senate passes FDA user fee reauthorization

FDA“The Senate overwhelmingly passed bipartisan legislation Thursday that reauthorizes U.S. Food and Drug Administration’s ability to collect user fees from drug and device makers.The FDA user-fee agreements, which are renegotiated every five years with the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, fund nearly half of the FDA’s operations.”

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US FDA Clarifies What Constitutes “minor” Change to Biologic Production Process

Petri DishUS FDA clarifies what constitutes ‘minor’ change to biologic production proces By Gareth MacDonald+, 09-Aug-2017:  The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week. The US Food and Drug Administration Draft Guidance sets out what changes to manufacturing process and facilities, production equipment and storage systems it considers to be “minor.”

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US FDA Plans Facility Inspection Efficiency Drive

Man looking at machine with clipboardUS FDA plans facility inspection efficiency drive By Flora Southey, 23-Aug-2017:  The US Food and Drug Administration (FDA) has released a document to address the integration of pharmaceutical facility evaluations and inspections.  The integration of FDA Facility and Inspection Programme for human drugs: A Concept of Operations agreement, coordinated by the Center for Drug Evaluation and Research (CDER) and the Offie of Regulatory Affairs (ORA), details the responsibility for pre-approval, post-approval surveillance and cause-for inspections in the US and abroad.

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US, EU advance collaboration efforts on manufacturing

“The Food and Drug Administration is allowing European regulators a more complete look at commercially confidential information linked to pharmaceutical production as part of a newly inked agreement. The move furthers a mutual goal among U.S. and European officials to streamline and improve inspections of drug manufacturing facilities. In February, the European Union and the FDA entered a pact in which the two regulatory bodies would trust each other’s conclusions from inspections conducted in their respective territories.”

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U.S. House passes bill to lengthen time to report medical device malfunctions

Man looking at machine with clipboard“The U.S. House passed a fee-reauthorization bill for the Food and Drug Administration on Wednesday that would triple the amount of time medical device companies have to report malfunctions of some higher-risk product. The change, outlined in a statement included by reference in the bill, would give companies 90 days to report product malfunctions, replacing the current 30-day deadline. The bill would also allow companies to summarize previously reported product malfunctions, rather than filing detailed reports on each case.”

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House passes bipartisan FDA user fee bill

FDA“The bill calls for more than $400 million in new user fees in fiscal 2018, and would incrementally increase fees each year thereafter. It would allow the FDA to hire more staffers and speed up approvals of drugs and devices, which could help healthcare companies streamline operations, supporters argue. Yet, critics claim that the rising fees disproportionately affect smaller companies, and expediting the review of drugs and medical devices could compromise quality.”

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The Growing Role of Automation in the Pharmaceutical Industry

cGMP“Automation in the laboratory has been around for decades, but historically accessibility and ease of use was reserved for high value processes. One example, in the pharma industry, is using liquid handling robots to improve reproducibility and increase the validity of data in high throughput screening (HTS). This is because automated systems are less likely to have variances in reagent quantities and HTS is a fairly consistent and repetitive process.”

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5 Trends Driving Disruption in the Med Device Industry in 2017

people working machinery“The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them.”

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How the FDA has changed, How the 483 has changed, & How we should use 483s to get smarter

“The most important change over the past ten years has been the FDA’s shift to become globally active in GMP enforcement as the drug supply chain changes. Some of the countries to which manufacturing is outsourced have differing interpretations of US GMPs and have regulatory authorities that may not be as mature as, for example, the FDA or EMA. The FDA is not the only regulatory authority impacted by this change.   As a result we see the FDA collaborating with other regulatory agencies, such as the EMA, so that both may make most effective use of their resources.”

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