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


Top 5 issues for medical device risk management and design controls

“Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Risk/Benefit analysis is required in clause 6.5 of ISO 14971, but there is very little guidance on what is expected.  How do risk/benefit analyses impact design controls?”


FDA’s Efforts to Advance the Development of Biologics

“The safety and efficacy of the biological products regulated by the FDA are inextricably linked to the quality and consistency of their manufacturing. This is as true now as it was when the Biologics Control Act of 1902 was enacted. Over a century of experience has informed our development of a holistic approach to the development and regulation of these products, from facilitating preclinical development to clinical development and on to post-market surveillance. This approach acknowledges the critical link between quality manufacturing and controls and the safety and efficacy of the products. To put it simply, for patients and the public to benefit from biological products, they must be made well.”


Medical DeviceWhat you need to know about reusable devices and Europe’s MDR

“The introduction of MDR is putting increased emphasis on the roles that robust data and complete evaluations play in ensuring medical device safety. All devices, including Class I reusable devices (Class Ir), must meet the new guidelines or risk being excluded from the market.”


EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs

“In the US and Europe, drug regulators approve new drugs based on whether the benefits of the new product outweigh the risks. But neither of the regulators consider if such new drugs are superior to drugs currently marketed. Now, three senior officials at the European Medicines Agency (EMA) explain how an added therapeutic benefit criterion or head-to-head comparisons could help to drive more innovative therapies.”



Dutch regulators weigh in on no-deal Brexit impact for medical device companies

“The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no agreement is reached (a ‘no deal’ scenario). In case of a no deal Brexit, existing legislation concerning medical devices and in-vitro diagnostics will no longer be applicable to the UK as of the withdrawal date at which the UK leaves the EU. The EU legislation does not change, but companies that are based in the UK or that distribute their devices via the UK to the EU must adapt to the new situation in which the UK will become a third, non-EU country.”


FDAFDA Tightening Regulatory Requirements For Some Medical Devices

“There’s no doubt that surgically implanted medical devices can improve lives. Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones. But implanted devices can also do serious damage, as happened to Mechel Keel, who lives in Owosso, Mich. To fix her leaky bladder, an OB-GYN stitched a flexible mesh strap inside her pelvis in 2004. But within months the mesh hardened and started cutting her insides. The pain kept her from returning to her job as a hairdresser. The injuries and scar tissue that developed required multiple surgeries to correct and also resulted in chronic infections.



CDER Guidance Agenda for 2019: What’s Coming

“The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural.”


Harvard to Offer Free Online Course on Pharma Controversies

“Beginning 26 March, three professors at Harvard Medical School will begin offering a new free online course on controversial topics related to FDA, prescription drug prices, off-label marketing and other programs like the priority review voucher and Orphan Drug Act. The course will also cover topics such as the safety evaluation of prescription drugs using real world data, topics stirring debate over the scope of FDA regulation, such as with dietary supplements, special classes of prescription drugs and “right to try” laws.



Issues of quality in pharmerging countries ‘more spoken about than real’

 By Ben Hargreaves

There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.



Medical devices regulation countdown

“Currently, there are more than 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Robust regulation that ensures a supply of safe devices, and allows monitoring of the introduction and use of medical devices, is essential. The new Medical Device Regulation (EU) 2017/745 was published in the Official Journal of the European Union and came into force on May 5, 2017, replacing two existing Directives…The new regulations apply after a transitional period. Namely, three years after entry into force of Regulation (EU) 2017/745 on medical devices (May 26, 2020), and five years after entry into force (May 26, 2022) of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.”

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Draft guidance on CDER’s program to recognize standards in pharmaceutical quality

“A draft guidance has been made available for industry entitled CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. This program, once established, should facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. This informal program will help streamline the compilation and assessment of marketing applications for products regulated by CDER.”

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Canada Steers Away From Using Suffixes in Biologics’ Names

“Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the US the only country in the world to use such suffixes. “Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix,” a notice to stakeholders said. “Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the same non-proprietary name can be distinguished by their unique brand names.”

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What are Brexit contingency plans for pharmaceutical industry?

Brexit poses a big threat to pharmaceutical research and manufacturing in the UK, the industry has said, potentially driving up manufacturing costs and deterring future investment. AstraZeneca and other companies have frozen all manufacturing investments. Britain’s second-biggest drugmaker decided to halt further investments at its Macclesfield site in the summer of 2017. Its chairman, Leif Johansson, has said the UK needs to make sure it “does not become an isolated island in the middle of the Atlantic Ocean.” David Jefferys, a senior executive at the European arm of the Japanese company Eisai, which makes treatments for Alzheimer’s disease, epilepsy and breast cancer, told the Guardian: “Nobody likes uncertainty. We are not making any new investments in the UK until there is clarity.”

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