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Filtering on: "topics labeling"

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Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance By Michael Mezher - Published 13 December 2017

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Labeling

Tags: Antimicrobial Susceptibility Interpretive Test Criteria, Breakpoint, 21st Century Cures

Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation By Yvonne Middlefell, FRAPS, RAC - Published 12 December 2017

This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration

Tags: IVDR, Annex 1, Risk Management

FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children By Michael Mezher - Published 29 November 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices.

Categories: News, FDA, Labeling, Medical Devices, Submission and registration

Tags: X-Ray Imaging, Radiation

Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance By Zachary Brennan - Published 27 November 2017

The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984. But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views.

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

Tags: Hatch-Waxman, generic drug competition, CREATES Act

Drug Labels: Experts Note Importance of Faster Updates By Zachary Brennan - Published 15 November 2017

The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday.

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

Tags: drug labels, cancer drug labels, Friends of Cancer Research

Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update By Gloria Hall - Published 07 November 2017

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling.

Categories: Features, Advertising and Promotion, Labeling, Nutritional and dietary supplements

Tags: Regulatory Focus, Feature Articles, Editorial

FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included By Zachary Brennan - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

Categories: News, US, FDA, Over the counter drugs, Labeling

Tags: aspirin, FDA label, cardiovascular images

Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels By Jesús Muñiz, MS - Published 27 October 2017

This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule.

Categories: Features, US, FDA, Labeling, Nutritional and dietary supplements

Tags: Dietary Supplements, Labeling, Label Changes, Supplements Fact Label

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

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

Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements By Zachary Brennan - Published 10 October 2017

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.

Categories: News, US, FDA, Drugs, Labeling, Packaging

Tags: child-resistant packaging, Boehringer Ingelheim, FDA draft guidance

EMA Adds New Excipients to Labeling Requirements By Michael Mezher - Published 09 October 2017

The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others.

Categories: News, EC, EMA, Drugs, Labeling

Tags: Excipients, Labeling, Package Leaflet

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

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

FDA Offers Draft Guidance to Further Secure Drug Supply Chain By Zachary Brennan - Published 21 August 2017

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging, Regulatory strategy

Tags: DSCSA, track and trace, FDA guidance, drug supply chain

FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs By Michael Mezher - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

Categories: News, US, FDA, Drugs, Labeling, Manufacturing

Tags: PharmaTech, Burkholderia cepacia, B. cepacia, Recall

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

EMA Restricts Use of Biogen MS Drug By Zachary Brennan - Published 07 July 2017

The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients "with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines."

Categories: News, Europe, EMA, FDA, Drugs, Labeling, Postmarket surveillance

Tags: Biogen, MS, EMA PRAC

FDA Revises Draft Guidance on Medical Gases By Michael Mezher - Published 28 June 2017

The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance detailing the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.

Categories: News, US, FDA, Compliance, Distribution, Labeling, Manufacturing

Tags: Medical Gas

FDA to Take Closer Look at Abuse-Deterrent Opioids By Michael Mezher - Published 13 June 2017

The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids.

Categories: News, US, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids

Updated: FDA Warns OTC Drugmaker for Inaccurate Listing Information By Michael Mezher - Published 06 June 2017

The US Food and Drug Administration (FDA) on Thursday warned over-the-counter drugmaker Prestige Brands Holdings over missing information in the structured product labeling (SPL) submitted to FDA for two of the company's drugs.

Categories: News, US, FDA, Over the counter drugs, Labeling

FDA Delays UDI Requirements for Low-Risk Devices By Michael Mezher - Published 05 June 2017

The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.

Categories: News, US, FDA, Labeling, Medical Devices, Packaging

Tags: Unique Device Identifier, UDI

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications

FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines By Zachary Brennan - Published 20 April 2017

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

Categories: News, US, FDA, Crisis management, Government affairs, Labeling

Tags: codeine, tramadol, label changes