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Filtering on: "topics labeling"

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FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017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The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC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

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016) By Nick Paul Taylor - Published 15 November 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, TGA, Biologics and biotechnology, Drugs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug advertising, social media and pharmaceuticals, Aurobindo Pharma

FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance.

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

Tags: Essure, Boxed warning, Patient decision checklist

Industry Groups Call for Clarity in New 510(k) Device Modifications Guidance By Michael Mezher - Published 14 November 2016

Prominent medical device manufacturers and industry groups are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on submitting a new 510(k) for changes to a medical device.

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

Tags: 510(k) device modifications

What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains By Zachary Brennan - Published 14 November 2016

For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.

Categories: News, Europe, EC, Business and Leadership, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ANSM, CE marking, notified bodies

Draft Guidance: FDA Calls for Contraindication for Ultrasonic Surgical Aspirators By Michael Mezher - Published 09 November 2016

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance recommending a contraindication and label changes for some ultrasonic surgical aspirators in light of the risk for the devices to spread cancer cells if used to remove uterine fibroids.

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

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

WHO Releases Draft Guidance on Postmarket Changes to Biologics By Michael Mezher - Published 03 November 2016

The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment.

Categories: News, WHO, Biologics and biotechnology, Labeling, Manufacturing, Submission and registration

Tags: Biologics, Biosimilars, Postmarket Changes

FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices By Michael Mezher - Published 31 October 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure.

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

Tags: Essure, Boxed Warning, Patient Decision Checklist

FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone By Zachary Brennan - Published 25 October 2016

The labels for all prescription testosterone products will now include a new warning and an updated Abuse and Dependence section to include safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). 

Categories: News, US, FDA, Crisis management, Drugs, Due Diligence, Labeling

Tags: testosterone, FDA warnings on steroids, body builders and steroids

FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database By Zachary Brennan - Published 25 October 2016

As part of efforts to reduce an increasing number of adverse events from home-use medical devices, FDA is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.

Categories: News, US, FDA, Labeling, Medical Devices, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: home-use medical devices, new FDA proposed rule, FDA rules

Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016) By Nick Paul Taylor - Published 18 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Labeling, Quality

Tags: Asia Regulatory Roundup, GSK, Abbott, data management

HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms By Michael Mezher - Published 04 October 2016

In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms.

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

Tags: UDI, Claims Forms, Accredited Standards Committee X12

When is a REMS Necessary: FDA Explains in Draft Guidance By Zachary Brennan - Published 30 September 2016

The draft guidance from the US Food and Drug Administration (FDA), unveiled earlier this month, tries to further explain the application of its risk evaluation and mitigation strategy (REMS) regulatory paradigm, which can delay generic drug competition.

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

Tags: REMS, generic drugs, FDA and REMS

FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo By Zachary Brennan - Published 15 September 2016

The US Food and Drug Administration (FDA) this week agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications for renal cell carcinoma, metastatic melanoma and non-small cell lung cancer. 

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Labeling

Tags: Opdivo, Bristol-Myers Squibb, Opdivo dosing