Whether you're a new or established user of Amazon's EBS here are seven functions you may not know about that can be used to optimize your system and ROI.

Keep on reading: 7 Little-Known Amazon EBS Features You Should Be Using

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing

The highly distinctive and mostly endemic Australian land mammal fauna has suffered an extraordinary rate of extinction (>10% of the 273 endemic terrestrial species) over the last ∼200 y: in comparison, only one native land mammal from continental North America became extinct since European settlement. A further 21% of Australian...

When evaluating public cloud providers on pricing, it is easy to get hung up on the differences. AWS and Google Cloud each have their own service catalog, terminology and purchasing variations. But do these differences actually impact the final bill?

Keep on reading: Google Cloud vs. AWS: Who Has The Best Pricing?

Sharing third-party AWS workflow options that can be integrated to increase your operation's effectiveness and productivity when working in the cloud. 

Keep on reading: Automating the Cloud: AWS Tools and Tips

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”).  The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that

The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics appeared first on Kleinfeld Kaplan & Becker LLP.

By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging.  Driven by this increased demand and desire to create positive environmental change, companies are working hard to shift to more sustainable materials and packaging and seeking to communicate such efforts to consumers through product labels and advertising.  “Recyclable.”  “Biodegradable.”  “Made of

The post It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims appeared first on Kleinfeld Kaplan & Becker LLP.

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.

The current pandemic is revealing the level of commitment needed from multiple sectors to deliver innovative solutions to tackle severe shortages of personal protective equipment, ventilators, and raw materials. Researchers at the Prakash lab at Stanford University are no stranger to taking up extreme challenges, and they have kept up their reputation by coming up […]

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

Medical device manufacturer, Boddingtons, has lately been resourcing fast-tooling and moulding projects in relation to emergency procurement for the Covid-19 crisis.

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.

Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.

MPN editor Laura Hughes reached out to Blake Teipel (BT), CEO and co-founder of Essentium, and Gurvinder Singh (GS), global product director, injection moulding at Protolabs, to find out how the companies were helping with the pandemic.

Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.

The Dyson CoVent ventilators are no longer required in the UK, according to a statement from Sir James Dyson.

Thermoformed packaging company Lacerta has managed to ship over three million Personal Protective Equipment (PPE) face shields to healthcare and frontline workers, in response to the coronavirus pandemic.

Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.

Prisym ID, a provider of data-led label and artwork management solutions, is offering instant access to its Prisym 360 SaaS medical devices labelling solution, to support medtech manufacturers’ response to Covid-19.

Olympus highlights two important standards for medical tubing, and explores inspection solutions that can help you meet them.

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.

Munich-based software start-up Climedo Health has published a whitepaper assessing the "Impact of Covid-19 on the medtech industry".

The new company called PlastiKCs, was founded by injection moulding expert Kurt Callewaert, together with Thiele & Kor Plastics Machinery, a long-standing representative of Sumitomo (SHI) Demag.

Röchling Engineering Plastics UK is supporting the medical and healthcare sectors with thermoplastic components and materials to assist the NHS and worldwide OEMs.

Chemicals company Lubrizol is helping with the pandemic by making materials used in Personal Protection Equipment (PPE) as well as hand sanitiser and products to help treat patients who are fighting the virus.

The research by Ben-Gurion University (BGU) and the National Institute of Biotechnology in the Negev (NIBN), has received financial support from the Israel Innovation Authority as part of a call for proposals for coping with the coronavirus.

Polyfuze Graphics, a global manufacturer of polymer fusion technology products for safety labelling and graphics, has introduced an antimicrobial safety product to help with Healthcare Associated Infections (HAIs) during the Covid-19 pandemic.

John Dogru, CEO of 3DPrinterOS, spoke to MPN’s editor Laura Hughes about the pivotal role of 3D printing during the Covid-19 pandemic.

Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro.

Experts react to role of distributors, legislation in opioid crisis