Search Results for SCOTUS

Showing 1 – 23

AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: News, US, FDA, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval By Zachary Brennan - Published 12 June 2017

The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Business and Leadership, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supreme Court of the United States, SCOTUS, biosimilars, patent dance

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

Sandoz Petitions Supreme Court to Rule on Biosimilars By Zachary Brennan - Published 17 February 2016

Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before bringing their product to market.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

Supreme Court Declines to Hear Case on Off-Label Prescribing Authority By Alexander Gaffney, RAC - Published 15 December 2014

The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated.

Categories: News, US, FDA, Drugs, Labeling

Tags: Supreme Court, SCOTUS, Planned Parenthood v. Humble, Court Case, Off-Label Prescribing

Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA By Alexander Gaffney, RAC - Published 04 September 2014

A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products.

Categories: News, US, FDA, Prescription drugs, Ethics

Tags: Off-Label, Planned Parenthood v. Humble, RU-486, Mifeprex, Mifeprestone, Lawsuit, SCOTUS, Supreme Court, Regulation of Off-Label Drugs

Supreme Court Again Rules in Favor of Generic Pharmaceutical Industry, Supports Federal Preemption By Alexander Gaffney, RF News Editor - Published 25 June 2013

Categories: US

Tags: Pliva v. Mensing, SCOTUS, Supreme Court

BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable By Alexander Gaffney, RF News Editor - Published 13 June 2013

Categories: US

Tags: Myriad, SCOTUS, AMP, Supreme Court

FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases By Alexander Gaffney - Published 05 October 2012

Categories: FDA, FTC

Tags: Writ of Certiorari, Pay-For-Delay, Pay For Delay, Lawsuit, Court, SCOTUS, Latest News, Supreme Court

Orange Book Listings Lesson: An overly broad use code may lead to legal challenges By Jane Wright-Mitchell, PharmD, JD - Published 23 July 2012

The US Supreme Court's recent Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S decision highlights the different viewpoints of the courts in the pharmaceutical arena, in particular drawing attention to the interaction of pharmaceutical patents to the US Food and Drug Administration (FDA)-generated Orange Book.

Categories: FDA

Tags: Caraco Pharmaceuticals, Orange Book, Novo Nordisk, Court, SCOTUS, ANDA, It's the Law, decision, legal

Supreme Court Upholds Majority of Affordable Care Act in Historic Decision By Alexander Gaffney - Published 28 June 2012

Tags: Affordable Care Act, ACA, SCOTUS, Obamacare, Latest News, Patient Protection and Affordable Care Act, PPACA, decision

How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies? By Alexander Gaffney - Published 27 June 2012

Tags: Affordable Care Act, ACA, Biopharmaceutical, Legislation, SCOTUS, Obamacare, Law, analysis, Latest News, pharmaceutical, Patient Protection and Affordable Care Act, PPACA, medical device

Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit By Alexander Gaffney - Published 12 June 2012

Tags: Aranesp, Epogen, Case, Amgen, Class Action, Securities, Lawsuit, Court, SCOTUS, Latest News

Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication By Alexander Gaffney - Published 18 April 2012

Tags: Entry, Caraco, Kagan, Novo Nordisk, 505(b)(2), Delay, SCOTUS, Generic, Latest News

Senator Plans to Introduce Legislation Reversing Mensing Decision By Alexander Gaffney - Published 29 March 2012

Tags: Pliva, Mensing, Legislation, Court, SCOTUS, Law, Generic, RLD, Latest News, Senate, Bill, Congress

What You Need To Know About The Supreme Court Hearing on the Affordable Care Act: Day Three By Alexander Gaffney - Published 28 March 2012

Tags: ACA, Court, Hearing, SCOTUS, Obamacare, Law, Latest News, Supreme Court, PPACA

What You Need To Know About The Supreme Court Hearing on the Affordable Care Act By Alexander Gaffney - Published 27 March 2012

Tags: ACA, Court, Hearing, SCOTUS, Obamacare, Law, Latest News, Supreme Court, PPACA

After Prometheus Case, SCOTUS Sends Gene Patent Ruling Back to Lower Court By Alexander Gaffney - Published 27 March 2012

Tags: BRCA, Myriad, Mayo, Prometheus, Breast Cancer, SCOTUS, Law, Latest News, Patent, Supreme Court

What You Need To Know About Today's Supreme Court Hearing on the Affordable Care Act By Alexander Gaffney - Published 26 March 2012

Tags: ACA, Court, Hearing, SCOTUS, Obamacare, Law, Latest News, Supreme Court, PPACA

EPA Case Could Imperil FDA Warning Letters By Alexander Gaffney - Published 26 March 2012

Categories: FDA

Tags: Administrative Procedure Act, Sackett v. EPA, EPA, Justice, warning letter, SCOTUS, Law, Latest News, decision, warning letters

Nestle Loses Patent Case That Could Have Stifled IVD Development By Alexander Gaffney - Published 20 March 2012

Tags: Mayo Clinic, Mayo, Breyer, Prometheus, Nestle, Justice, Court, SCOTUS, Latest News, Supreme Court

Healthcare Reform Case to go Before SCOTUS in Two Weeks By Alexander Gaffney - Published 12 March 2012

Tags: Arguments, Justice, SCOTUS, Law, Latest News, Supreme Court, BPCI, PPACA

Obama Administration, Plaintiffs File PPACA Briefs By Alexander Gaffney - Published 09 January 2012

Categories: DOJ

Tags: SCOTUS, Obamacare, Law, Brief, Amicus Curiae, States, Latest News, PPACA, legal