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



What you need to know about Europe’s new medical device rules

“The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent one of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market. With just a three- to five-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, the scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. Manufacturers will need to identify which of their products will be affected by the new classifications to ensure they remain compliant.

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FDA Takes Step Toward Additional Global Pharmaceutical Manufacturing Inspections

FDA“Officials with the FDA will recognize 8 European drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as capable of conducting inspections of manufacturing facilities that meet FDA requirements, according to a statement from the agency released today.


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The complicated news on device recalls

“There were only 167 device recalls in Q3, which is down 39 percent from the previous quarter and the lowest it’s been since the fourth quarter of 2011. On the other hand, the number of actual units being recalled went up 1 percent to 68 million. The average recall size was 407,000 units. This actually looks okay with a little context.


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‘No longer the stuff of science fiction’ – US FDA publishes regenerative med policies

Biologics“The US FDA has published a series of guidelines to spur development of regenerative medicines while ensuing safety and efficacy of such products.

 By Dan Stanton


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Apple, Fitbit, Samsung, and Verily among FDA’s picks for precertification pilot

“Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofar as the most of the company’s offerings are not FDA-cleared.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool

FDA“On Thursday, the FDA launched a new dashboard to facilitate access to reports of adverse drug reactions. By making the FAERS database more easily accessible through the dashboard, the agency’s goal is to better inform patients and health care professionals of adverse events reported with drug and biologic products. FAERS can be a valuable tool but it is just one of many data sets that helps inform the agency of possible problems associated with a product.”

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UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

Biologics“Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterization and quality control, ensuring analytical method performance and facilitating bioanalytical method development.”

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7-Year FDA Review Reveals Importance of Rotating Plant Inspectors

Investigations“Nobody likes product recalls: they undermine consumer confidence in a brand and cost manufacturers time and money. Unfortunately, minimizing the risk of a recall is easier said than done. Identifying the factors that contribute to unforeseen product defects is complicated, but the results of a seven-year review by the Food and Drug Administration (FDA) have revealed a simple way to reduce product recalls for medical devices.

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Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

Pharmaceutical“Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual report. The draft guidance notes that 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 biologic applicants in an annual report.”

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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 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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