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Filtering on: "topics labeling"

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Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance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

FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions By Zachary Brennan - Published 18 January 2017

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market.

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

Tags: Jazz Pharmaceuticals, Xyrem, generic approvals

FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: News, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: RLD, generic drugs, ANDA, ANDA submission

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

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

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

FDA Issues Labeling Guidance for Aspirin, Acetaminophen By Michael Mezher - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products.

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

Tags: Aspirin, Acetaminophen

Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers By Zachary Brennan - Published 09 January 2017

The Food and Drug Administration (FDA) on Tuesday will release draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements.

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

Tags: DSCSA, wholesale drug distributor, drug logistics, FDA guidance

2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning By Zachary Brennan - Published 20 December 2016

Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June).

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Labeling, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical regulations, year in review, Cures, Trump

New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women By Zachary Brennan - Published 14 December 2016

The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains.

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

Tags: anesthesia, sedation, toddlers and surgery, pregnant women and sedation

FDA Classifies Post-Concussion Test By Michael Mezher - Published 05 December 2016

Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.

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

Tags: ImPACT, Concussion, Post-Concusion, Class II, De Novo

FDA Finalizes Guidance on Labeling By Michael Mezher - Published 02 December 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Labeling

Tags: Clinical pharmacology

European Regulatory Roundup: EMA Releases Draft Guidance on Using Pictograms on Packaging (1 December 2016) By Nick Paul Taylor - Published 01 December 2016

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Labeling, Packaging

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

FDA Calls Out Unproven Claims of Unapproved Blood Device By Zachary Brennan - Published 28 November 2016

Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels.

Categories: News, US, CBER, Advertising and Promotion, Labeling, Medical Devices, Quality

Tags: Dr. PRP America, blood plasma levels, PRP Kit, centrifuge