Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Reed Smith
What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support. Part One was last week.
BakerHostetler
Most recently, the states of Mississippi and Arkansas have been sued by plant-based food producers over these laws.
BakerHostetler
FDA Releases Q&A on Nonclinical Toxicology Studies – The FDA published a draft guidance titled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers."
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Dek: Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product
Oblon, McClelland, Maier & Neustadt, L.L.P
Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost
Hogan Lovells
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS)
Hogan Lovells
On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC).
BakerHostetler
Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.
BakerHostetler
District Court in Arkansas entered a consent decree against a facility that warehoused food, drug products and medical products under unsanitary
BakerHostetler
FDA guidance on evaluating the safety of flood-affected food crops. The FDA issued a reminder to "harvesters that generally,
BakerHostetler
issued a revised "Advice about Eating Fish for Women Who Are or Might Become Pregnant, Breastfeeding Mothers
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.
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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.
Wolf, Greenfield & Sacks, P.C.
Today, companies are developing AI systems to meaningfully analyze the deluge of biomedical data.
Reed Smith
We recently blogged about the final chapter (at the district court level, anyway) of the big defense win in the Mirena MDL.
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.
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
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
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.
Fenwick & West LLP
Rock Health reported that $4.2 billion was invested in digital health companies during the first half of 2019.
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.
Arnold & Porter
In the past, such proposals have largely been met with resistance by the FDA.
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