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Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics By Zachary Brennan - Published 07 February 2017

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which was first approved by FDA in 1986.

Categories: News, US, FTC, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Vancocin, c. difficile, Eli Lilly, Shire, citizen petitions

FTC Continues Crackdown on Pay-for-Delay Agreements By Zachary Brennan - Published 23 January 2017

The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements that often keep generic drugs from entering the US market.

Categories: News, US, FTC, Generic drugs, Due Diligence, Government affairs, Regulatory strategy

Tags: pay-for-delay settlements, Endo, Allergan, Watson Laboratories, Impax

Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016) By Zachary Brennan - Published 16 November 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, DOJ, EMA, FDA, FTC, MHRA, NICE, PMDA, TGA, Biologics and biotechnology, Business and Leadership, Clinical, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs By Zachary Brennan - Published 15 November 2016

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.

Categories: News, US, FTC, Advertising and Promotion, Over the counter drugs, Due Diligence, Quality

Tags: drug marketing, OTC drugs, homeopathic drugs

FDA Begins Process of Overhauling Off-Label Communications Regulations By Zachary Brennan - Published 31 August 2016

The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pharmaceutical off-label communications, Amarin, drug company free speech

Regulatory Recon: Roche’s Zika Test Wins Emergency Authorization From FDA (29 August 2016) By Zachary Brennan - Published 29 August 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, CDSCO, FDA, FTC, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen By Zachary Brennan - Published 22 August 2016

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: News, US, FDA, FTC, Business and Leadership, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays By Zachary Brennan - Published 04 August 2016

Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its moneymaker.

Categories: News, US, FTC, Business and Leadership, Generic drugs, Regulatory intelligence

Tags: Provigil, Cephalon, Teva, pay for delay

Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition By Zachary Brennan - Published 27 July 2016

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: News, US, FTC, Crisis management, Generic drugs, Manufacturing, Project management

Tags: Teva, Allergan, generic drugs, generic drug competition

New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition By Zachary Brennan - Published 15 June 2016

Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products.

Categories: News, US, DOJ, FDA, FTC, Business and Leadership, Crisis management, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug competition, CREATES Act, REMS

PBMs, Payers Exclude Coverage for Growing Number of Priciest Drugs By Zachary Brennan - Published 12 May 2016

Two of the largest pharmacy benefit managers (PBMs) in the US are excluding a growing number of costly drugs from their formularies (ie. the drugs are not eligible for reimbursement), as the fight over drug costs is beginning to take a turn toward clinical and cost-effectiveness.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Clinical, Drugs, Reimbursement

Tags: CVS, Express Scripts, PBM, expensive drug costs

Device Supplier Settles Monopoly Allegations With FTC By Zachary Brennan - Published 28 April 2016

UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market.

Categories: News, Europe, US, FTC, Business and Leadership, Crisis management, Distribution, Due Diligence, Manufacturing, Medical Devices, Regulatory strategy

Tags: PEEK, medical device suppliers, polymer suppliers, Invibio, Evonik, Solvay

FDA Collaborates With FTC on Mobile Health App Regulatory Tool By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.

Categories: News, US, FDA, FTC, Business Skills, Compliance, Government affairs, Medical Devices

Tags: mHealth regulation, mobile health apps, health applications

FTC Sues Drugmakers for Not Marketing Authorized Generics By Zachary Brennan - Published 31 March 2016

The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws.

Categories: News, US, FTC, Compliance, Crisis management, Government affairs, Product withdrawl and retirement

Tags: FTC, no-AG commitments, pay-for-delay, generic entry, exclusivity

Congress Offers New Details on Drug Price Spikes By Zachary Brennan - Published 02 February 2016

Ahead of a Thursday hearing with US Food and Drug Administration (FDA) CDER Director Janet Woodcock sitting beside former Turing CEO Martin Shkreli, the House Oversight Committee has released documents where the former hedge fund manager calls the price hikes of a toxoplasmosis treatment “a very handsome investment.”

Categories: News, US, FDA, FTC, Active pharmaceutical ingredients, Business and Leadership, Drugs, Reimbursement

Tags: toxoplasmosis, Daraprim, Shkreli, drug price increases

FTC: Pay-For-Delay Deals Decrease Significantly After Supreme Court Ruling By Zachary Brennan - Published 14 January 2016

The number of pay-for-delay settlements decreased significantly in 2014 after a Supreme Court decision in 2013 found that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate antitrust laws.

Categories: News, US, FTC, Drugs, Ethics, Government affairs, Regulatory strategy

Tags: FTC, pay-for-delay, generic competition

Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes By Zachary Brennan - Published 09 December 2015

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Reimbursement

Tags: drug pricing, Martin Shkreli, Turing, Daraprim, off patent drug prices, Senate committee

US Government Agencies Crack Down on Dietary Supplement Manufacturers By Zachary Brennan - Published 17 November 2015

In partnership with the Department of Justice, Federal Trade Commission and other agencies, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

Categories: News, China, US, DOJ, FDA, FTC, Compliance, Distribution, Manufacturing, Nutritional and dietary supplements

Tags: USPlabs, FDA, DOJ, FTC, dietary supplements, nutraceuticals, good manufacturing practices

New Calls for Supreme Court to Weigh in on Unilateral Drug Labeling, 'Product Hopping’ By Zachary Brennan - Published 10 November 2015

The US Supreme Court is considering two requests that could have an impact on US Food and Drug Administration (FDA) rules governing drug label changes, and whether brand name drug manufacturers have to take generic competition into account when pulling a product from the market.

Categories: News, US, FDA, FTC, Compliance, Drugs, Due Diligence, Labeling, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Johnson & Johnson, Motrin, drug labels, FDA, product hopping, generic competition

Senators Investigate Rising Drug Prices as HHS Plans Action By Zachary Brennan - Published 04 November 2015

The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging with letters to four companies.

Categories: News, US, DOJ, FDA, FTC, Business Skills, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Elijah Cummings, Valeant Pharmaceuticals, drug prices, Senate investigation

Industry, Patient Groups Weigh in on FDA's Biosimilar Naming Guidance By Michael Mezher - Published 29 October 2015

Industry is calling on the US Food and Drug Administration (FDA) to use to use "meaningful" and "distinguishable" suffixes linked to a biosimilar license holder's name, according to comments on the proposed naming system.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Biological naming, Nonproprietary Naming of Biological Products, Biological Qualifier, Biosimilar

Regulatory Recon: 21st Century Cures Struggles in the Senate (27 October 2015) By Zachary Brennan - Published 27 October 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Europe, US, DOJ, EMA, FDA, FTC, MHRA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, In vitro diagnostics, Medical Devices, Research and development

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Clinton Urges FDA, FTC to Take Action Against Drug Price Hikes By Zachary Brennan - Published 19 October 2015

In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market.

Categories: News, US, FDA, FTC, Distribution, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: FTC, FDA, Ostroff, Hillary Clinton, Daraprim, Turing Pharmaceuticals