Search Results for Lawsuit

Showing 1 – 25  of 42

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

Group Sues FDA, Seeking Access to Ebola Information By Alexander Gaffney, RAC - Published 10 June 2015

A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: The Goldwater Institute, Ebola, FOIA, Lawsuit

Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal By Alexander Gaffney, RAC - Published 07 October 2014

The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Labeling, Postmarket surveillance

Tags: Generic Drug Labeling, Generic Drug Labeling Rule, GPhA, Ralph Neas, Lawsuit

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

Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex By Alexander Gaffney, RAC - Published 29 April 2014

Categories: US, FDA

Tags: Patent Reissue, Generic Drug, 180-Day Exclusivity, Mylan, Lawsuit, OGD, ANDA, Latest News, pharmaceutical

AbbVie Withdraws Legal Challenge Against EMA Regulatory Transparency Policy By Alexander Gaffney, RAC - Published 04 April 2014

Categories: EMA

Tags: AbbVie, Data Transparency, InterMune, Clinical Data, Lawsuit, Latest News, EU

Hawaii Sues BMS, Sanofi Over Genetic Limitations of Plavix By Alexander Gaffney, RAC - Published 20 March 2014

Categories: US

Tags: Attorney General, Hawaii, Plavix, Lawsuit, Latest News

Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada By Alexander Gaffney, RAC - Published 19 February 2014

Categories: US, FDA

Tags: Gilead, Truvada, AHF, AIDS, HIV, Lawsuit, Court, Latest News, legal

After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ By Alexander Gaffney, RF News Editor - Published 27 August 2013

Categories: US, DOJ, FDA

Tags: Sterile, Lawsuit, Consent Decree, Latest News, cGMP

AIDS Group Wins Bid to Obtain 'Confidential' Data Analysis, Summaries About HIV Drug from FDA By Alexander Gaffney, RF News Editor - Published 08 August 2013

Categories: US, FDA

Tags: Clinical Data, Gilead, Truvada, FOIA, Lawsuit

Wyeth Agrees to Pay $491 Million to Resolve Federal Off-Label Marketing Charges By Alexander Gaffney, RF News Editor - Published 30 July 2013

Categories: US, DOJ

Tags: Wyeth, Pfizer, Lawsuit

In Major Reversal, EMA Ordered by EU Court to Halt Clinical Trials Transparency Initiative By Alexander Gaffney, RF News Editor - Published 30 April 2013

Categories: EMA

Tags: Lawsuit, clinical trials, EU

Pharmaceutical Company's Regulatory Missteps Tempt Shareholder Legal Action By Alexander Gaffney, RF News Editor - Published 18 March 2013

Tags: Impax, Form 483, warning letter, Lawsuit

Court Rules that Consent Decree Overrules Company's Claims of FDA Inspector Malfeasance By Alexander Gaffney, RF News Editor - Published 24 January 2013

Categories: FDA

Tags: Lawsuit

FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues By Alexander Gaffney, RF News Editor - Published 12 November 2012

Categories: FDA

Tags: Whistleblowers, Case, Judge, FOIA, Whistleblowing, FDA Nine, Lawsuit, Latest News, legal

J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner By Alexander Gaffney - Published 05 October 2012

Tags: Shareholder, Risperdal, Janssen, J&J, Kessler, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

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

Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA By Alexander Gaffney - Published 02 October 2012

Categories: FDA, CDRH

Tags: Kohn, NWC, National Whistleblowers Council, Reviewers, Whistleblowers, Taylor, FDA Nine, Shuren, Lawsuit, Latest News, medical device

In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld By Alexander Gaffney - Published 07 September 2012

Categories: FDA

Tags: 17P, Makena, KV Pharmaceuticals, Compounding, Judge, Lawsuit, Court, Latest News

J&J to Pay Millions in Marketing Lawsuit Published 31 August 2012

Tags: Johnson, Risperdal, J&J, Settlement, Lawsuit, Latest News

Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy By Alexander Gaffney - Published 06 August 2012

Categories: FDA

Tags: Premature Birth, Preterm Birth, 17P, K-V Pharmaceutical, KV Pharmaceutical, Makena, Enforcement Discretion, Lawsuit, Latest News

FDA: Challenge to Enforcement Discretion Without Standing, Merit By Alexander Gaffney - Published 26 July 2012

Categories: FDA

Tags: Premature Birth, Preterm Birth, 17P, K-V Pharmaceutical, KV Pharmaceutical, Makena, Enforcement Discretion, Lawsuit, Latest News

Court Orders FDA to Release Thousands of Documents on Surveillance Program By Alexander Gaffney - Published 24 July 2012

Categories: FDA

Tags: NWC, FOIA, Whistleblowing, Surveillance, FDA Nine, Lawsuit, Court, Latest News

Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal By Alexander Gaffney - Published 17 July 2012

Categories: FDA, FTC

Tags: Leibotiz, Pay-For-Delay, Pay For Delay, Lawsuit, Court, Amicus Curiae, Latest News

Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices By Alexander Gaffney - Published 16 July 2012

Categories: FDA, CDRH

Tags: Kohn, NWC, National Whistleblowers Council, Reviewers, Whistleblowers, Taylor, FDA Nine, Shuren, Lawsuit, Latest News, medical device