Search Results for drug labels

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Australia Outlines Major Drug Label Changes By Zachary Brennan - Published 09 August 2016

Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find.

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Drugs, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Australia drug labels, drug label, drug labeling changes, dispensing label

Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn By Zachary Brennan - Published 08 July 2016

The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness.

Categories: News, US, FDA, Drugs, Labeling

Tags: generic drug labels, ANDA, withdrawn reference product

‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing By Zachary Brennan - Published 27 May 2016

The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Labeling, Medical Devices

Tags: off-label marketing, Pacira, Amarin, Vascular Solutions, FDA and drug labels

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate By Zachary Brennan - Published 19 May 2016

The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts.

Categories: News, FDA, Biologics and biotechnology, Drugs, Government affairs, Labeling

Tags: generic drug labels, FDA rule, Public Citizen, adverse events

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

Health Canada to Require Precautionary Statements in Antimicrobial Labels By Zachary Brennan - Published 16 November 2015

As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling.

Categories: News, Canada, Health Canada, Active pharmaceutical ingredients, Crisis management, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: Health Canada, antimicrobials, antibiotics, superbugs, drug labels, labeling

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

FDA to Approve ANDAs on the Basis of Draft Labeling By Zachary Brennan - Published 05 October 2015

The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.

Categories: News, US, FDA, Generic drugs, Due Diligence, Government affairs, Labeling, Packaging, Regulatory intelligence, Regulatory strategy

Tags: ANDA, draft labeling, drug labels, FDA guidance, FPL, OGD

New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes By Alexander Gaffney, RAC - Published 20 August 2014

US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling, Medical Devices

Tags: openFDA, MAUDE, SPL, Drug Labels, MDR, Medical Device Adverse Event, AE