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Building a Health App? Part 2: Protecting Your Intellectual Property

This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful...more

Sandoz Announces New Data For Its Adalimumab Biosimilar

by Goodwin on

Last week, Sandoz announced new data reportedly showing that its proposed adalimumab biosimilar matches the safety and efficacy profile of Humira®. The data was obtained from a long term study of patients with...more

The Way Forward for Telemedicine

by McDermott Will & Emery on

A lot of us have argued that one of the floodgates for telemedicine has been reimbursement. If states and the Federal government more liberally reimbursed or required reimbursement for telemedicine service, we argue then a...more

Sham Affidavits

by Reed Smith on

We’re quite familiar with people who say one thing, when they think that’s in their interest, and later when circumstances change, say something quite different. For example, as the late, great Molly Ivins pointed out in...more

Health Alert (Australia) 25 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 20 September 2017 - Non-inquest findings into the death of RO'H 2013/761 - 'Mr RO'H died at Logan Hospital after being...more

Medtronic Receives Regulatory Approval for Surgical Navigation Device

by Knobbe Martens on

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices

by Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Approves First-Ever Mobile App for Addiction Treatment

by Knobbe Martens on

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

by Arnall Golden Gregory LLP on

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

by Arnall Golden Gregory LLP on

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July...more

In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more

CHMP Adopts Positive Opinions on BI’s CYLTEZO® and Samsung Bioepis’s ONTRUZANT®

by Goodwin on

On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...more

Health Update - September 2017

Using Telehealth as a Tool for Health System Integration - As discussed in our August Health Update article on patient engagement and digital health—the first in our new digital health series—the advent of digital and...more

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Research into Cannabidiol (CBD) Progresses

by Knobbe Martens on

Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This...more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Legal Implications and Initial Takeaways from the Equifax Data Breach

On September 7, Equifax, one of three nationwide credit-reporting agencies that compile and evaluate the financial history of consumers, announced that it suffered a security breach in which sensitive information of...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

Social Media Success: Trends in Pharma Digital Strategies

by Knobbe Martens on

Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital marketing strategies over the next one to two years....more

Recall Highlights Medical Device Cybersecurity Issues

by Knobbe Martens on

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

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