Search Results for Labeling

Showing 1 – 25  of 52

FDA Draft Guidance for Medical Product Communications By Alan Bergstrom - Published 13 September 2017

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."

Categories: Features, FDA, Communication, Labeling

Tags: Communication, Labeling

Child-Resistant Packaging Statements in Drug Labels: FDA Drafts Guidance By Zachary Brennan - Published 02 August 2017

The US Food and Drug Administration (FDA) on Wednesday published draft guidance to help ensure child-resistant packaging (CRP) statements in drug labels is clear, useful, informative and, to the extent possible, consistent in content and format.

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

Tags: child-resistant packaging, drug labeling, drug packaging

FDA Makes Drug Safety Labeling Change Information Easier to Access By Zachary Brennan - Published 01 September 2016

The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats.

Categories: News, US, FDA, Drugs, Labeling

Tags: safety labeling changes, CDER database, MedWatch

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

Plain Language Labelling Requirements By Christelle Gedeon - Published 05 August 2016

This article describes the requirements of the guidance document published by Health Canada on plain language labelling.

Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Labeling

Tags: Plain language labeling

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

Health Canada Finalizes IVD Labeling Guidance After 18 Years By Michael Mezher - Published 25 April 2016

The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998.

Categories: News, Canada, Health Canada, In vitro diagnostics, Labeling

Tags: Electronic Labeling, E-labeling, Blood glucose monitoring systems

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 Releases Long-Awaited Draft Guidance on Biosimilar Labeling By Zachary Brennan - Published 31 March 2016

The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product.

Categories: News, US, FDA, Biologics and biotechnology, Labeling, Project management, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Research and development

Tags: biosimilar labels, biosimilar approval, reference product labeling

Asia Regulatory Roundup: Pharmacy Sues CFDA Over Drug Monitoring System (2 February 2016) By Nick Paul Taylor - Published 02 February 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Biologics and biotechnology, Drugs, Labeling, Medical Devices

Tags: CFDA, drug monitoring, Pakistan drugs, Alibaba, device labeling

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

FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen By Zachary Brennan - Published 16 November 2015

The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours.

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

Tags: Acetaminophen, Tylenol, liver warning, liver damage, OTC, FDA labeling guidance

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

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

Stronger Warnings on 18 NSAIDs After Review Finds Increased Cardiovascular Risk By Michael Mezher - Published 10 July 2015

The US Food and Drug Administration (FDA) will soon ask drugmakers to update the labels for all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after reviewing mounting evidence linking the drugs to increased risk for heart attack and stroke.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Labeling, Postmarket surveillance, Product withdrawl and retirement

Tags: NSAIDs, nonsteroidal anti-inflammatory drugs, warning, boxed warning, labeling, Vioxx, Bextra

Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids By Alexander Gaffney, RAC - Published 08 June 2015

A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug.

Categories: News, US, CDER, Drugs, Labeling

Tags: Opioids, Labeling, Black Box, Legislators, Letter, ER Opioids, IR Opioids

In Petition to FDA, AbbVie Argues Biosimilars Need Distinctive Labeling By Alexander Gaffney, RAC - Published 04 June 2015

"Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week.

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

Tags: Biosimilars, Biosimilar Labeling, Citizen Petition, 505(q) Petition

Plain Language Labeling Regulations to Take Effect in Canada By Michael Mezher - Published 02 June 2015

Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Labeling, Packaging, Submission and registration

Tags: Plain language labeling, Medication errors, Adverse drug reactions, ADRs

Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event By Zachary Brousseau - Published 29 May 2015

As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. RAPS’ virtual event Advertising, Promotion and Labeling: the US Regulated Environment will bring together experts to offer their advice.

Categories: HTML, Articles, Under RAPS, RAPS Events, US, FDA, FTC, RAPS, Advertising and Promotion, Compliance, Labeling

Tags: advertising, promotion, labeling, social media, social media regulation, FDA, FTC

FDA Seeking Safer Medical Devices Through eLabeling Pilot By Alexander Gaffney, RAC - Published 20 April 2015

Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).

Categories: News, US, CDRH, Labeling, Medical Devices

Tags: Labeling, Device Labeling, Home Use Devices, Home Use Devices Initiative, Labeling Repository

How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out By Alexander Gaffney, RAC - Published 06 April 2015

US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of a device prior to its use.

Categories: News, US, CDRH, In vitro diagnostics, Labeling, Medical Devices

Tags: Medical Device Labeling, Study, Medical Device Labeling Standardization

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's Electronic Drug Labeling Proposal Comes Under Fire By Alexander Gaffney, RAC - Published 25 March 2015

The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk.

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

Tags: Electronic Drug Labeling Rule, Package Insert, Electronic Labeling, Proposed Rule, Proposed Regulation, FDA Regulation

With US' First Biosimilar Approval Expected This Week, is FDA's Biosimilar Labeling Guidance Imminent? By Alexander Gaffney, RAC - Published 05 March 2015

The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US' first biosimilar, Sandoz' Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there's a good chance the biopharmaceutical industry won't have to wait long for the release of that guidance.

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

Tags: Biosimilar, Biosimilar Labeling Guidance, Guidance, Draft Guidance, INN