Search Results for Generic Drug Labeling

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Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling Rule By Zachary Brennan - Published 13 April 2016

As Congress looks to pass a spending bill for FY 2017 by Friday, the House Appropriations Committee has released a new bill with a modest amount of new funding for the US Food and Drug Administration (FDA) and new demands on how FDA should write a controversial and major final rule on generic drug labels.

Categories: News, US, FDA, Generic drugs, Labeling, Postmarket surveillance

Tags: generic drug labeling, Congressional spending, House appropriations

FDA to Release Major Generic Drug Labeling Rule in July 2016 By Zachary Brennan - Published 03 December 2015

The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Ethics, Government affairs, Labeling

Tags: generic drug labeling, FDA, drug labels, safety labeling

Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System By Alexander Gaffney, RAC - Published 30 March 2015

In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks.

Categories: News, US, CDER, Drugs, Labeling

Tags: Generic Drug Labeling, Generic Drug Safety, Expedited Agency Review, EAR, PhRMA, GPhA

Trial Lawyers, Favoring FDA's Generic Drug Labeling Rule, Blast Generic Drug Industry Study By Alexander Gaffney, RAC - Published 26 March 2015

A trade group representing trial lawyers is fighting back against a 2014 report by the generic pharmaceutical industry which claimed a rule proposed by the US Food and Drug Administration (FDA) to allow generic drug companies to help update drug labels could cost the industry billions and raise drug costs for consumers.

Categories: News, US, CDER, Generic drugs, Labeling

Tags: Generic Drug Labeling Rule, American Association for Justice, Trial Lawyers, Generic Drug Labeling

FDA Reopens Debate Over Major Generic Drug Labeling Rule By Alexander Gaffney, RAC - Published 17 February 2015

Despite rumors of its demise, the US Food and Drug Administration’s (FDA) controversial plan to allow generic drug companies to update their labels to reflect new and emerging safety information isn’t dead—not yet, at least.

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

Tags: Generic Drug Labeling, Generic Drug Labeling Rule, Proposed Rule

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

House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior By Alexander Gaffney, RAC - Published 18 July 2014

A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group.

Categories: News, US, CDER, Generic drugs

Tags: Generic Drug, ANDA, CBE-0, Generic Drug Labeling Rule, House, Legislators

Beyond Parity: Lowering Adverse Drug Event Risk through Incentivized Pharmacogenetics By Kermit Jones MD, JD - Published 16 June 2014

The US Food and Drug Administration (FDA) recently proposed a new rule to address postapproval generic drug labeling. This articles argues that in order to actually lower the risk of these incidents occurring, FDA should instead create a program that incentivizes manufacturers to work with health professionals to perform postapproval pharmacogenetic and pharmcogenomic (PGx) studies in patients who have suffered serious adverse drug reactions (ADRs).

Categories: Features, US, CDER, Generic drugs

Tags: PGx, Pharmacogenetics, Pharmacogenomics, Generic Drug Labeling Rule, Generic Drug Labeling, CBE, Pliva v. Mensing, Failure-to-Warn, ADR,

Regulatory Explainer: Understanding the Regulation of Generic Drug Labels By Alexander Gaffney, RAC - Published 08 April 2014

Categories: US, FDA, Labeling

Tags: Drug Labeling, Regulatory Explainer, Proposed Rule, CBE, Generic Drug Labeling Rule, Generic Drug, Latest News, pharmaceutical, drug

In Response to Legislators, FDA Defends Proposed Generic Drug Labeling Rule By Alexander Gaffney, RAC - Published 11 March 2014

Categories: US, FDA

Tags: Proposed Rule, Generic Drug Labeling Rule, CBE-0, Generic Drug, ANDA, Latest News, pharmaceutical, drug

Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters By Alexander Gaffney, RAC - Published 06 March 2014

Categories: US, FDA

Tags: Proposed Rule, CBE, Generic Drug Labeling Rule, Generic Drug, Legislators, Latest News