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



Regulatory challenges top list of concerns of medtech professionals in annual survey

Medical Device“he survey of medtech professionals that regulatory consultancy Emergo (Austin, TX) conducts each year is a good gauge of the mood of the global medical device industry as it heads into a new year. Typically, there are no dramatic shifts in attitudes and perceptions from one year to the next—progress and change tend to be incremental in the medtech sector—but there is movement on the margins that can be instructive.”


CDER in warning letter frenzy as pharma struggles with quality control

documenting“Warning letters from the Food and Drug Administration’s Center for Drug Evaluation and Research spiked last year as drugmakers struggled to maintain quality control at their manufacturing sites, according to a new report from PwC. Though the FDA actually issued 22% fewer warning letters overall in 2017 versus 2016, the number coming from its CDER unit rose 35% for a total of 85.


PwC Analysis: Fewer New Regulations in 2017, But No Major Course Change at FDA

FDA“While 2017 was a standout year for the US Food and Drug Administration (FDA), many aspects of the agency’s work were business as usual in a year that saw a new president and new leadership at FDA…And according to PwC’s analysis, 2017 saw the lowest number of economically significant new regulations in the last 20 years. The agency also promulgated fewer new and proposed regulations than in all but four of those years, though the regulation totals included FDA’s work in food, devices and other industries outside of biopharma.”




FDA changes biologics inspections from biennial to risk-based

Petri DishFDA published a direct final rule Thursday to alter what it calls outdated regulations on biologic inspections. The old requirements mandated facilities be inspected at least once within 2 years of being registered, and then at least once every two years afterward.”


FDA releases top 3 medical device regulation goals

Medical Device“FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

MHRA Rolls Out Online Portal

documenting“The Medicines and Healthcare products Regulatory Agency (MHRA) is moving medical device firms over to new online accounts. MHRA is undertaking the transition as part of an attempt to streamline the services it provides to medical device companies by creating an online portal and other actions. Officials at the United Kingdom regulatory agency began moving medical device companies over to the new accounts at the end of November and expect to complete the transition next month. After that, all medical device companies will have a single account through which all online interactions with MHRA take place.”

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FDA Releases Medical Device 3D Printing Guidelines

FDA“The U.S. Food and Drug Administration (FDA) recently announced the publication of a 31-page set of guidelines for manufacturers producing medical products via 3D printing/additive manufacturing (AM). Although this information is presented as non-binding recommendations, the agency says it is the first in the world to provide such a comprehensive regulatory framework.”




New Year’s resolution time: FDA reveals goals for 2018

“That time of year is fast-approaching, and the Food and Drug Administration is looking ahead to its policy goals for 2018. The agency is declaring its major policy goals for 2018, as part of its twice-yearly Unified Agenda of Federal Regulatory and Deregulatory Actions.”


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FDA clears first medical device accessory for Apple Watch

“The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a user’s heart rate, detects when something is amiss and prompts the user to take an electrocardiogram..


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Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

BIOLOGICS“On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” about how to conduct analytical evaluation of similarity in biosimilars, was published on the website  Several biopharma majors were among the commenters, including Amgen, Boehringer Ingelheim (BI), Genentech, a Roche company, Novartis, Pfizer, Sanofi, and Shire. Other industry stakeholders include the Association for Accessible Medicines (AAM), the Biosimilars Forum, and the Biotechnology Innovation Organization (BIO).

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3D printing could expand medical device regulation: Here’s how

Compliance Training“FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions…Gottlieb highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing..

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