Posts filtered by tags: Fda[x]


In The Final Days Of Trump Administration, Agencies Clashed Over How To Regulate Medical AI

The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
Tags: Technology, Law, Fda, Trump Administration

US supreme court reinstates restrictions on abortion pill

Justices lift order that had suspended rule requiring in-person visits during Covid crisisCoronavirus – latest updatesSee all our coronavirus coverageThe US supreme court has reinstated a requirement that women visit a hospital or clinic to obtain a drug used for medication-induced abortions, lifting an order by a lower court allowing the drug to be posted or delivered during the coronavirus pandemic.The justices granted a request by the Trump administration to lift a federal judge’s July order ...
Tags: Health, Law, Women, US, Life and style, Society, World news, US news, US politics, Food And Drug Administration, Abortion, US healthcare, Fda, Women's Health, US supreme court, Trump

Justices grant FDA request to block mail delivery of abortion pills

The Supreme Court on Tuesday granted a request from the Food and Drug Administration to reinstate a federal requirement that a pill used to induce abortion in the early stages of pregnancy be picked up in person from a health care provider. A federal district judge had suspended that requirement last summer because of the COVID-19 pandemic and then left that ruling in place after the justices in October directed the FDA to return to the lower court to seek narrower relief. The Supreme Court’s ne...
Tags: Featured, Maryland, Supreme Court, Law, Court, Joe Biden, Indiana, United States, Food And Drug Administration, Nebraska, Fda, Biden, Trump, Sonia Sotomayor, John Roberts, U S District Court

4 Takeaways From FDA’s Emergency Vaccine Reviews

What lessons can future COVID vaccine candidates take from the FDA’s response to Pfizer and Moderna’s study data?
Tags: Law, Government, Fda, Pfizer, Health Care / Medicine, Moderna, Healthcare Docket

Injury-in-Fact and Standing to Appeal from the AIA-Trial Decisions

New petition for writ of certiorari in an interesting Hatch-Waxman and the question of Article III standing in appeals of AIA-Trial Decisions. Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation (Supreme Court 2020) Introducing generic alternatives that compete with previously approved drugs requires market approval through the Food and Drug Administration (“FDA”). To do so, competitors submit an Abbreviated New Drug Application (“ANDA”) that relies on the safety and efficacy...
Tags: Law, Congress, Food And Drug Administration, Fda, AIA, Patent, PTO, Hatch Waxman, Federal Circuit, Petitioner, Respondent, ANDA, Leahy Smith America, Leahy Smith, AIA Trial Decisions Argentum Pharmaceuticals LLC, Novartis Pharmaceuticals Corporation Supreme Court

America's longest-serving marijuana prisoner freed after 31 years

Richard DeLisi, now 71, was sentenced to 90-year prison term in 1989 for marijuana trafficking, as part of era’s ‘war on drugs’A man believed to be the longest-serving inmate for non-violent, marijuana charges has been released from a Florida prison, and is set to spend the holidays with family for the first time in more than 31 years. Related: First US Covid vaccinations expected next week as FDA emergency approval appears close – live Continue reading...
Tags: Florida, Human Rights, Law, America, Society, World news, US news, Cannabis, Fda, US prisons, Richard DeLisi

FDA advisory panel recommends approval of Pfizer Covid vaccine for emergency use

Recommendation signals formal FDA approval for Pfizer/BioNTech vaccine in the US could be imminentAn advisory panel to the US Food and Drug Administration has recommended the emergency approval of a Covid-19 vaccine developed by Pfizer and BioNTech.The recommendation is expected to signal that the first approval of a Covid-19 vaccine for use in the US is imminent. That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally. Continue...
Tags: Health, Science, US, Society, World news, US news, Fda, Vaccines and immunisation, Pfizer, US Food and Drug Administration, Coronavirus

Coronavirus Update 12-7-2020: Vaccines

We are days away from the FDA approving two different COVID-19 vaccines, and it is being reported that the first people could start receiving the vaccine as early as Friday.While I covered the topic of employer-mandated vaccines earlier this year, I understand that everyone doesn't necessarily see or read every post I write. Thus, because of just how important this issue will quickly become for employers, today I'm directing you to my thoughts from three months ago: Coronavirus Update 9-1-2020: ...
Tags: Law, Fda, Ada, National Cancer Institute, Jon Hyman

Patent Eligibility of Claims Directed to Printed Matter

by Dennis Crouch C R Bard Inc. v. AngioDynamics, Inc., No. 19-1756 (Fed. Cir. 2020) (Opinion by Judge Reyna, joined by Judges Schall and Stoll). = = = = Important: The court in this case particularly holds that “a claim may be found patent ineligible under § 101 on the grounds that it is directed solely to non-functional printed matter and the claim contains no additional inventive concept.” = = = = Question: How does the printed-matter-doctrine apply to letters that can only be read using an X-...
Tags: Law, Court, Fda, Patent, Alice, Fed, Bard, Bruce, Praxair, Reyna, Johns, Federal Circuit, C R Bard Inc, Stoll, AngioDynamics Inc, AngioDynamics

Petitioning the Government as an Act of Infringement

by Dennis Crouch Valeant Pharmaceuticals v. Mylan Pharmaceuticals (Fed. Cir. 2020) Prior to TC Heartland, Federal Circuit precedent equated proper venue with personal jurisdiction — finding venue proper in any court that had personal jurisdiction over the defendant. See 28 U.S.C. § 1391.  In 2017, however, the Supreme Court gave renewed force to the text of 28 U.S.C. § 1400(b). Any civil action for patent infringement may be brought [1] in the judicial district where the defendant resides, or ...
Tags: UK, Maryland, Supreme Court, Law, West Virginia, United States, New Jersey, Fda, Pfizer, Patent, Morgantown, Valeant Pharmaceuticals, Hyderabad India, Federal Circuit, Eli Lilly and Co, MPI

Sanctions for Deleting Pre-Lawsuit Emails

by Dennis Crouch The court issued an important short-opinion, In re Ivantis, Inc. (Fed. Cir. 2020), that should be read and considered as a case-study by in-house counsel. The case involves pre-lawsuit destruction of evidence. The basic setup is that Ivantis has a corporate email-destruction-policy* of deleting emails that are 12-months old.  Glaukos sued Ivantis for infringement in April 2018 and served the defendant with the Summons and Complaint on April 16, 2018. On April 19, 2018 the compa...
Tags: Law, Fda, Patent, Federal Circuit, IPR, FRCP, Glaukos, Dennis Crouch, Ivantis Inc Fed, Ivantis

Symposium: Coronavirus litigation lurks in the shadows

This article is part of a symposium on the Supreme Court’s “shadow docket.” Stephen Wermiel writes the “SCOTUS for law students” column for SCOTUSblog. He is a professor of practice at American University Washington College of Law, where he teaches constitutional law and a seminar on the Supreme Court. The Supreme Court has been wrestling with a steady stream of legal issues related to the coronavirus pandemic, all in the form of emergency applications decided without full briefing or oral argum...
Tags: Texas, Featured, Maryland, Supreme Court, Law, California, Virginia, Chicago, Commerce, San Diego, Food And Drug Administration, Fda, Nevada, Louisiana, Illinois, Orange County

Justices delay action on FDA request to reinstate abortion-pill restrictions

The Supreme Court on Friday put off action on a request from the Food and Drug Administration to reinstate a federal requirement that a pill used to induce abortion in the early stages of pregnancy be picked up in person from a health care provider. A federal district court in Maryland had suspended the requirement in July, concluding that requiring in-person visits during the COVID-19 pandemic violates the Constitution. The FDA asked the justices in August to block the district court’s order wh...
Tags: Featured, Maryland, Supreme Court, Law, United States, Food And Drug Administration, Fda, Ruth Bader Ginsburg, Howe, Alito, Samuel Alito, American College of Obstetricians, Acog, Chuang, Theodore Chuang, U S Court of Appeals for the 4th Circuit

Inducing Infringement by Making a Product Available

GlaxoSmithKline LLC v. Teva Pharmaceuticals (Fed. Cir. 2020) GSK’s patent at issue here covers a method of treating congestive heart failure with the drug carvedilol (Coreg) along with an ACE inhibitor, a diuretic  and digoxin.  RE40,000. Claim 1 below is representative and shows the limitation added during the reissue process: 1. A method of decreasing mortality caused by congestive heart failure in a patient in need thereof which comprises administering a therapeutically acceptable amount of ...
Tags: Post, Law, US, Fda, Patent, Newman, Moore, Mizzou, GSK, AB, Teva, Federal Circuit, Prost, ANDA, GlaxoSmithKline LLC, Erika Lietzan

Thursday round-up

With the first Monday of October just four days away, journalists and commentators are looking ahead to what the Supreme Court’s new term might bring. At Bloomberg Law, Ellen Gilmer previews the environmental cases that may come before the court this term. In the final episode of the first season of the Legal Docket podcast, Mary Reichard and Jenny Rough look ahead to the term’s most high-profile cases, including the constitutional challenge to the Affordable Care Act. In a blog post for the Nat...
Tags: Supreme Court, Law, Bloomberg, Fda, Npr, Donald Trump, Ada, Round-up, Senate Judiciary Committee, Jess Bravin, Nina Totenberg, Barrett, Pacific Legal Foundation, Purcell, National Conference of State Legislatures, Acog

Mental health startup eQuoo will be distributed by Unilever in new global youth campaign

Last December (yes, in the before-times) UK-based mental health startup eQuoo had a round of announcements, becoming the NHS approved mental health game, as well as signing Barmer, the largest insurance company in Germany, as a client. It’s now been selected as the Mental Health App for Unilever’s new global initiative aimed at the mental health of young people. The move came after Unilever’s People Data Centre (PDC) selected eQuoo out of all the mental health games on the Google Playstore, b...
Tags: Psychology, Google, TC, Apps, Europe, UK, Germany, Articles, Insurance, Tech, Unilever, Ceo, Artificial Intelligence, Mental Health, NHS, European Commission

US, Russia, China won't join global initiative to offer fair access to COVID-19 vaccines. Why not?

More than 150 countries have joined an initiative to develop, produce, and fairly distribute an effective COVID-19 vaccine.But China, Russia, and the U.S. have declined to join in a bid to win the vaccine race.The absence of these three economies risks the success of the global initiative and future collaborations. The board game "Pandemic" tasks players with stopping deadly diseases as they spread across the world. But what separates "Pandemic" from its winner-take-all peers is that it's a col...
Tags: Politics, Drugs, White House, China, Russia, Society, Public Health, United States, Innovation, Who, World Health Organization, Fda, Pharmaceuticals, Vaccines, Donald Trump, Trump

Friday round-up

Coverage and commentary on President Donald Trump’s expanded list of potential Supreme Court nominees continues. NPR’s Nina Totenberg examines how some of the new candidates differ from those on previous iterations of the list. “While the previous three lists included just one elected politician and no administration officials, this list includes three U.S. senators — all fire-breathing conservative Republicans,” Totenberg reports. “All three have, directly or indirectly, criticized Chief Justic...
Tags: Texas, Supreme Court, Law, California, Barack Obama, New York Times, Fda, Npr, Donald Trump, Greenhouse, Trump, Round-up, Bush, John Roberts, Mark Joseph Stern, Coyle

Physicians tell justices not to disturb lower-court ruling that eased access to abortion pill during pandemic

Lawyers for the American College of Obstetricians and Gynecologists urged the Supreme Court on Tuesday to leave in place a lower-court order that allows patients, during the coronavirus pandemic, to avoid a requirement that they visit a medical office in order to obtain a pill used to induce abortion in the early stages of pregnancy. The Food and Drug Administration has asked the justices to freeze that order and reinstate the federal requirement that the drug be picked up in person from a healt...
Tags: Featured, Maryland, Supreme Court, Law, United States, Fda, Howe, The Food and Drug Administration, American College of Obstetricians, OB, Acog, Jeffrey Wall, U S Court of Appeals for the 4th Circuit, Emergency appeals and applications

The First Amendment Protects the Marketing Term “Vegan Butter”–Miyoko’s v. Ross

I have been a vegetarian for 35+ years. Over the past 15+ years, I have shifted towards being vegan. I eat virtually 100% vegan in the home and always prefer vegan options when they are available. My embrace of veganism has partially coincided with the proliferation of vegan restaurants and grocery store options. We live in a golden era of vegan/”plant-based” mass-market products, with a wonderful diversity and quality of options that put to shame Loma Linda’s 1980’s-era canned vegetarian hot do...
Tags: Law, Marketing, Wisconsin, Fda, Hampton Creek, Ross, Loma Linda, Turtle Island, Content Regulation, Miyoko, California Department of Food Agriculture, Gitson, RS N D Cal

Senior FDA/Health Care Associate Attorney [Sponsored]

Thriving Dallas office of a decorated national firm has an immediate need for a Senior Associate to join the firm's Health Care/FDA practice.
Tags: Asia, Texas, Law, Dallas, Fda, Health Care, Sponsored Content, Job Posting, Kinney Recruiting, Asia Chronicles, Food and Drug Administration (FDA, FDA Health Care, s Health Care FDA

Google Defeats Account Termination Case on Section 230 Grounds (Mostly)–Enhanced Athlete v. YouTube

This is another account termination case. The plaintiff ran two YouTube channels with 145k subscribers. The opinion implies that the channels hyped a steroid-like supplement not approved by the FDA (“SARMS”). As usual with cases in this genre, the plaintiff claimed that YouTube acquiesced to these videos until it capriciously changed its mind, at which point it improperly nuked the channels. Thus, the plaintiff sued “to stop Defendants from unlawfully censoring its educational and informational...
Tags: Google, Facebook, Instagram, Law, Youtube, Marketing, Fan, Fda, Enigma, Malwarebytes, Lewis, Barnes, New Hampshire Supreme Court, Content Regulation, Derivative Liability, Darnaa

The dangers of the chemical imbalance theory of depression

A study at Harvard's McLean Hospital claims that using the language of chemical imbalances worsens patient outcomes. Though psychiatry has largely abandoned DSM categories, professor Joseph E Davis writes that the field continues to strive for a "brain-based diagnostic system."Chemical explanations of mental health appear to benefit pharmaceutical companies far more than patients. The pharmacological revolution began with tranquilizers. Miltown was the country's first "blockbuster" drug. Toute...
Tags: Psychology, Health, America, Neuroscience, Society, Mental Health, Depression, Harvard, Medical Research, Innovation, Davis, Fda, Freud, Derek, Ny Times, Twitter Facebook

FDA Guidance On Cannabis Research: A Glimpse Of What’s To Come For CBD Products?

The FDA guidance goes on to address an unexpected and highly debated issue.
Tags: Law, Marijuana, Fda, Cbd, Nathalie Bougenies, Cannabidiol (CBD, FDA Guidance On Cannabis Research

Repeated Amazon Purchases Sufficient to Impute Notice of Arbitration Clause

We blogged Nicosia v. Amazon in 2015 and 2016. (See “The “Browsewrap”/”Clickwrap” Distinction Is Falling Apart”; “Anarchy Has Ensued In Courts’ Handling of Online Contract Formation (Round Up Post).”) A recent Second Circuit ruling in favor of Amazon, while unpublished, warrants a mention. This lawsuit involved weight-loss products, purchased on Amazon, which had been removed from the market at the FDA’s request. The district court initially found in favor of Amazon with respect to its argument...
Tags: Google, Amazon, Law, E-commerce, United States, Fda, Faa, Trudeau, Nicosia, District Court, Ninth Circuit, Second Circuit, Amazon com Inc, Nosal, Llewellyn, Reinhardt

The FDA Continues To Kick The CBD Can Down The Road

The FDA says it's not yet in a position to regulate these products and ensure public safety.
Tags: Law, Marijuana, Fda, Nathalie Bougenies, Cannabidiol (CBD

Opinion analysis: Court rejects challenge to exemptions from birth-control mandate

The Affordable Care Act’s birth-control mandate requires most employers to provide their female employees with health insurance that includes access to certain forms of contraceptives. In 2017, the Trump administration issued new rules that expanded an exemption from the mandate to allow private employers with religious or moral objections to opt out of providing coverage without any notice. Today, by a vote of 7-2, the Supreme Court in Little Sisters of the Poor v. Pennsylvania rejected a chall...
Tags: Featured, Supreme Court, Law, Obama, Congress, Court, Pennsylvania, United States, New Jersey, Fda, Catholic, Ruth Bader Ginsburg, ACA, Trump, Thomas, Sonia Sotomayor

Biosimilars and Temporary Restraining Orders

by Dennis Crouch Genentech and City of Hope v. Immunex and Amgen (Fed. Cir. 2020) Genentech’s bevacizumab (Avastin) is a large-molecule biologic cancer chemotherapy.  The FDA approved (licensed) Amgen’s biosimilar (aka generic) version – that is sold as Mvasi.  As a biosimilar, the approval process was quicker and cheaper for Amgen because the FDA relied upon some of the data originally provided by Genentech. Under the Biologics Price Competition and Innovation Act (BPCIA), the biosimilar produc...
Tags: Law, Fda, AFL, Patent, Fed, Genentech, Amgen, Westlaw, Federal Circuit, Amgen Inc, City of Hope, Sandoz Inc, Nikken, GENETECH, Immunex, Dennis Crouch Genentech

Patchwork Of Judicial Decisions Exacerbates Confusion On Legality Of CBD Products

Until the FDA starts to serve its role of regulator, CBD companies, especially deep-pocketed ones, should obtain sound legal advice regarding federal and state regulations.
Tags: Law, Marijuana, Fda, Nathalie Bougenies, Cannabidiol (CBD

Will this Limit on Patent Term Extension Drive a Rewriting of Hatch-Waxman?

The court today denied two en banc petitions: Biogen International GmbH v. Banner Life Sciences LLC, 20-1373 (Fed. Cir. 2020) The law allows for a limited extension of patent term based upon regulatory delays – such as FDA delay in approving a drug for sale.  The statute is unfortunately complex and poorly written. 35 U.S.C. 156. In this case, Biogen received a patent term extension for its Patent US7619001 associated with using the drug Tecfidera (MS treatment). By the time of the litigation, t...
Tags: Law, Congress, Fda, Patent, Fed, Hatch Waxman, Biogen, Federal Circuit, IPR, Kevin Noonan, Dish Network LLC, Biogen International GmbH, Banner Life Sciences LLC, Dragon Intellectual Property

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