Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Arnold & Porter
On May 26, 2017, the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force.
Dentons
The TGA has successfully brought a claim against Peptide Clinics Australia Pty Ltd for non-compliance with the new advertising regime which includes higher penalties for therapeutic goods advertising offences.
BakerHostetler
The 21st Century Cures Act (Cures Act), signed into law on Dec. 13, 2016, was designed to accelerate medical product development and bring new innovations
BakerHostetler
According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior.
BakerHostetler
The FDA published a new guidance for labeling of added sugars.
Wilson Elser Moskowitz Edelman & Dicker LLP
Nick Martin (Partner-San Francisco) co-authored "Let's Talk Talc: Litigation Defense Strategies Require Drilling Down" in the August 2019 edition of CLM Magazine.
Hogan Lovells
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
Reed Smith
We recently blogged about the final chapter (at the district court level, anyway) of the big defense win in the Mirena MDL.
Reed Smith
Today we bring you a terrific Daubert defense win. But, we'll be honest it's long. Really long. Thorough, but long. So, we're going to hit the highlights.
Lewis Roca Rothgerber Christie LLP
Trademarks are a large component of what makes a brand like Roche so valuable and one of the reasons why companies pay up to an estimated $500,000 for branding services when releasing a new drug.
Reed Smith
We have always thought that regulatory approval or clearance of a drug or medical device should weigh heavily against punitive damages, or even preclude punitive damages altogether.
Reed Smith
Offhand, we cannot think of opinions we have blogged on that pleased us more than today's cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC,...
Mintz
In June 2019, the Delaware Supreme Court issued a decision reaffirming director liability where there is no board-level reporting process for essential compliance matters.
Fenwick & West LLP
The year 2019 so far has proven to be strong for initial public offerings.
Akin Gump Strauss Hauer & Feld LLP
On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program("Open Payments")
Reed Smith
On our office bulletin board, we keep a post-it listing the states we have not yet visited. We are down to ten, and we expected to cross Oregon off after a deposition last week.
Wolf, Greenfield & Sacks, P.C.
Today, companies are developing AI systems to meaningfully analyze the deluge of biomedical data.
Cooley LLP
Manufacturers also should consider potential system enhancements and other changes that will be necessary to implement these updates if the Proposed Rule is finalized by CMS.
Arnold & Porter
In the past, such proposals have largely been met with resistance by the FDA.
Morrison & Foerster LLP
Mary Prendergast is an associate in MoFo's Washington, D.C. office. Her practice focuses on intellectual property and commercial litigation
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Arnold & Porter
On May 26, 2017, the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force.
Akin Gump Strauss Hauer & Feld LLP
In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD.
Wolf, Greenfield & Sacks, P.C.
Today, companies are developing AI systems to meaningfully analyze the deluge of biomedical data.
Fenwick & West LLP
Rock Health reported that $4.2 billion was invested in digital health companies during the first half of 2019.
Reed Smith
Did you ever wish there was a way to get a definitive answer to those age-old issues that have been plaguing humans since the beginning of time?
Reed Smith
Today's guest post is by Tucker Ellis‘ Dick Dean, a longtime friend of the blog and outspoken advocate of using the Dormant Commerce Clause as a one-two punch
Lewis Roca Rothgerber Christie LLP
Trademarks are a large component of what makes a brand like Roche so valuable and one of the reasons why companies pay up to an estimated $500,000 for branding services when releasing a new drug.
Fenwick & West LLP
The year 2019 so far has proven to be strong for initial public offerings.
Arnold & Porter
In the past, such proposals have largely been met with resistance by the FDA.
Reed Smith
We received positive feedback on our recent post on the Vaccine Act, so a recent Sixth Circuit opinion affirming a dismissal under the Act caught our eye
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