Search Results for REMS

Showing 1 – 25  of 50

Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

Categories: News, US, FDA, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Gottlieb: Immediate Release Opioids to be Subject to REMS By Michael Mezher - Published 28 September 2017

FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids.

Categories: News, US, FDA, Prescription drugs

Tags: Opioids, Immediate Release Opioids, IR, REMS, Risk Evaluation and Mitigation Strategy

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: REMS, Hatch-Waxman, generic drug competition

FDA Transparency: Gottlieb Outlines What’s Coming By Zachary Brennan - Published 14 September 2017

FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Scott Gottlieb, CRL transparency, REMS

Novo Nordisk Pays $58M to Settle REMS Allegations By Michael Mezher - Published 06 September 2017

Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).

Categories: News, US, DOJ, FDA, Advertising and Promotion, Communication, Drugs

Tags: Novo Nordisk, Victoza, REMS

E-Submissions of REMS Documents: FDA Offers Draft Guidance By Zachary Brennan - Published 01 September 2017

The US Food and Drug Administration (FDA) on Friday released draft guidance describing how it plans to implement requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.

Categories: News, US, FDA, Drugs

Tags: REMS, e-submissions FDA

Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse By Michael Mezher - Published 26 June 2017

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Generic Competition

Gottlieb Looks to Boost Generic Drug Competition By Michael Mezher - Published 21 June 2017

As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Competition, Generic Drugs

FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests By Michael Mezher - Published 20 June 2017

At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

Categories: News, US, FDA, Generic drugs, Orphan products

Tags: FY2018 Budget, Appropriations, Orphan Drug Designations, REMS, Scott Gottlieb

House and Senate Revive Bill Targeting Generic Drug Delays By Zachary Brennan - Published 27 April 2017

Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

Categories: News, US, FDA, Clinical, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CREATES Act, generic drug delay, REMS, Leahy

‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs By Zachary Brennan - Published 10 April 2017

A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs.

Categories: News, US, FDA, Distribution, Generic drugs, Government affairs

Tags: generic drug bill, pay for delay, REMS, delaying generic drug entry

House Committee Probes Restricted Distribution Systems Delaying Generics By Michael Mezher - Published 24 March 2017

The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.

Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies

When is a REMS Necessary: FDA Explains in Draft Guidance By Zachary Brennan - Published 30 September 2016

The draft guidance from the US Food and Drug Administration (FDA), unveiled earlier this month, tries to further explain the application of its risk evaluation and mitigation strategy (REMS) regulatory paradigm, which can delay generic drug competition.

Categories: News, US, FDA, Drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: REMS, generic drugs, FDA and REMS

Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses By Zachary Brennan - Published 21 June 2016

The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market.

Categories: News, US, FDA, Drugs

Tags: CREATES Act, REMS, Senate Judiciary

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

FDA Approves New Label for Lower Dose of Abortion Drug By Michael Mezher - Published 30 March 2016

In a win for public health advocates, the US Food and Drug Administration (FDA) on Wednesday approved new labeling for the abortion drug Mifeprex (mifepristone), supporting its safety and effectiveness when taken at lower doses and later in pregnancy.

Categories: News, FDA, Drugs, Labeling

Tags: Mifeprex, mifepristone, REMS

FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration By Michael Mezher - Published 06 October 2015

The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems.

Categories: News, US, FDA, Blood, Drugs, Regulatory strategy

Tags: REMS, Risk evaluation and mitigation strategies, Structured product label, SPL

FDA Unveils New Website Improvements to Help Industry Keep Track of REMS By Alexander Gaffney, RAC - Published 17 June 2015

The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US.

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

Tags: REMS, Risk Evaluation and Mitigation Strategies

FDA Explains how Companies can Modify a Drug Safety Assurance Plan By Alexander Gaffney, RAC - Published 06 April 2015

A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling, Postmarket surveillance

Tags: REMS, Guidance, Final Guidance, Risk Evaluation and Mitigation Strategies, Prior Approval Supplement, CBE, Changes Being Effects, PAS

FDA Makes it Easier to Bring Generic Copies of Dangerous Drugs to Market By Alexander Gaffney, RAC - Published 04 December 2014

A new draft policy issued by the US Food and Drug Administration (FDA) would makes changes to a complicated safety policy in the hopes of making it easier for generic drug manufacturers to make cheaper copies of dangerous drugs.

Categories: News, US, CDER, Biologics and biotechnology, Distribution, Drugs, Labeling, Postmarket surveillance

Tags: REMS, ETASU, Guidance, Draft Guidance, REMS Draft Guidance, Delay

Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved By Alexander Gaffney, RAC - Published 22 September 2014

A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market.

Categories: News, US, CDER, Biologics and biotechnology, Generic drugs, Prescription drugs, Regulatory strategy, Submission and registration

Tags: REMS, Fair Access for Safe and Timely (FAST) Generics Act, Legislation, Risk Evaluation and Mitigation Strategies

FDA Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians By Alexander Gaffney, RAC - Published 22 September 2014

The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products.

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

Tags: REMS, Pilot Projects, REMS Improvements

Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds By Alexander Gaffney, RAC - Published 24 July 2014

A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended.

Categories: News, US, CDER, Generic drugs, Submission and registration

Tags: REMS, Risk Evaluation and Mitigation Strategies, Study, GPhA, Generic Drug

FDA to Consider Giving Sponsors More REMS Communication Plan Options By Alexander Gaffney, RF News Editor - Published 26 November 2013

Categories: US, FDA

Tags: REMS