Search Results for FDA draft guidance

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Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability By Zachary Brennan - Published 04 May 2017

The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs

Tags: biosimilars, FDA draft guidance, Biosimilars Forum

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Submission and registration

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs).

Tags: bioequivalence studies, generic drugs, FDA draft guidance

AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices By Zachary Brennan - Published 27 September 2016

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance

Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance By Zachary Brennan - Published 19 August 2016

Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets.

Categories: News, US, FDA, Clinical, Compliance, Drugs, Manufacturing, Quality

Tags: chewable tablets, chewable drugs, pharmaceutical comments on FDA guidance, FDA draft guidance

UDI Form and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 25 July 2016

The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule.

Categories: News, US, FDA, Business and Leadership, Labeling, Medical Devices, Postmarket surveillance, Submission and registration

Tags: unique device identifier, UDI, UDI guidance, FDA draft guidance

Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs By Zachary Brennan - Published 17 February 2016

A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document.

Categories: News, US, EMA, FDA, Clinical, Compliance, Drugs, Due Diligence, Postmarket surveillance, Quality, Submission and registration

Tags: IND safety reporting, safety assessment committee, FDA draft guidance

New FDA Draft Guidance for Orthopedic Device Developers By Zachary Brennan - Published 11 February 2016

The US Food and Drug Administration (FDA) on Thursday released new draft guidance to help Class II and III orthopedic device developers understand what type of information to include in their submissions for devices using ultrahigh molecular weight polyethylene (UHMWPE) material.

Categories: News, US, FDA, Clinical, Due Diligence, Medical Devices, Packaging, Project management, Research and development

Tags: FDA draft guidance, orthopedic device guidance, UHMWPE

FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients By Zachary Brennan - Published 27 January 2016

To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs.

Categories: News, US, FDA, Active pharmaceutical ingredients, APIs, Clinical, Generic drugs, Due Diligence, Regulatory strategy, Research and development

Tags: bioequivalence studies, active ingredients, ANDAs, FDA draft guidance

Interoperable Medical Devices: FDA Offers Design, Labeling Considerations By Zachary Brennan - Published 25 January 2016

With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling.

Categories: News, US, CDRH, Due Diligence, Labeling, Medical Devices, Regulatory strategy

Tags: interoperable devices, medical devices online, device interoperability, FDA draft guidance

PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes By Zachary Brennan - Published 08 January 2016

The US Food and Drug Administration (FDA) should work more closely with the International Conference on Harmonization (ICH) on the reporting of chemistry, manufacturing and controls (CMC) changes for approved drugs and biologics, according to the industry groups’ comments on proposed FDA draft guidance.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing, Regulatory strategy

Tags: CMC changes, FDA draft guidance, guidance comments

FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes By Zachary Brennan - Published 20 October 2015

Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval application (PMA) supplement will want to consult with draft guidance from the US Food and Drug Administration (FDA) released Tuesday.

Categories: News, US, FDA, Compliance, Due Diligence, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: PMA, FDA, premarket approval, medical device manufacturing, FDA draft guidance

The Evolving Approach of Presenting Risk Information to Consumers By Richard Lem, PharmD - Published 25 September 2015

This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Drugs, Government affairs, Medical Devices

Tags: Office of Prescription Drug Promotion, FDA, draft guidance, social media, drug ads on social media