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Filtering on: "topics labeling"

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REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.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Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements By Zachary Brennan - Published 10 October 2017

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.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Tags: child-resistant packaging, Boehringer Ingelheim, FDA draft guidance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

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers By Zachary Brennan - Published 03 April 2017

The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations.

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

Tags: contact lens, UDI, unique device identification, GUDID

FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval By Michael Mezher - Published 29 March 2017

A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market.

Categories: News, US, FDA, Drugs, Labeling, Product withdrawl and retirement

Tags: Boxed Warning, Priority Review

European Commission Recommends Changes to SmPC, Package Leaflets By Michael Mezher - Published 27 March 2017

The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs.

Categories: News, Europe, EC, EMA, Drugs, Labeling

Tags: Summary of Product Characteristics, SmPC, Package Leaflet

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars By Zachary Brennan - Published 15 February 2017

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, nonproprietary names for biosimilars, nonproprietary names for biologics, FDA guidance

Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada By Linda Bowen, MS, RAC, João Duarte, MPharm - Published 01 February 2017

This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Regulatory strategy, Submission and registration

Industry Argues Against FDA Home-Use Device Label Database By Michael Mezher - Published 27 January 2017

The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels.

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

Tags: AdvaMed, Home-use medical devices

Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications By Zachary Brennan - Published 18 January 2017

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance