Search Results for Draft Guidance

Showing 1 – 25  of 237

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients By Michael Mezher - Published 23 March 2017

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy

Tags: Delayed Graft Function, DGF, Draft Guidance

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug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Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance By Zachary Brennan - Published 03 January 2017

Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information are coming to an end, possibly as soon as 2019.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Manufacturing

Tags: pharmaceutical manufacturing, draft guidance, manufacturing information

CDRH Lays Out Guidance Plans for FY 2017 By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, draft guidance for medical devices, device manufacturer guidance from FDA

FDA Revises Quality Metrics Guidance, Says Program Will Be Voluntary Until 2018 By Michael Mezher - Published 23 November 2016

The US Food and Drug Administration (FDA) on Wednesday released a revised version of its proposal to collect quality metrics data from drugmakers in response to protests from industry.

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

Tags: Quality Metrics, Revised 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

FDA to Revise Draft Guidance on Quality Metrics Data By Zachary Brennan - Published 12 September 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs, Manufacturing, Quality

Tags: quality metrics, pharmaceutical quality, FDA quality metrics guidance, CDER 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

New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities By Michael Mezher - Published 03 August 2016

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Manufacturing

Tags: Compounding, Compounded drugs, Outsourcing Facility, 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

FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets By Michael Mezher - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets.

Categories: News, US, FDA, Clinical, Drugs, Submission and registration

Tags: Chewable Tablets, Draft Guidance, Critical Quality Attributes

European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (16 June 2016) By Nick Paul Taylor - Published 16 June 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Quality, Regulatory strategy

Tags: Brexit, draft guidance, PSURs

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Research and development

Tags: Viekra Pak, Eli Lilly, AstraZeneca, generic drug draft guidance, generic drug development

FDA Issues Draft Guidance on NGS Sequencing for Infectious Disease Diagnostics By Michael Mezher - Published 12 May 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases.

Categories: News, US, FDA, Clinical, In vitro diagnostics

Tags: NGS, Next generation sequencing, Draft Guidance

GOP Senators Raise Concerns With FDA’s Draft Guidance Policies By Zachary Brennan - Published 06 May 2016

Four Republican senators sent a letter on Friday to US Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency’s inability to revise, finalize or withdraw draft guidance documents in a timely manner.

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

Tags: draft guidance, FDA policy on guidance documents

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

WHO on Prequalified IVDs: Changes Must be Reported By Zachary Brennan - Published 15 February 2016

Manufacturers of prequalified in vitro diagnostics (IVD) must submit change reports to the World Health Organization or risk having their product de-listed from the compendium of prequalified IVDs.

Categories: News, Asia, Europe, US, WHO, Compliance, Due Diligence, Government affairs, In vitro diagnostics, Manufacturing

Tags: prequalified in vitro diagnostics, World Health Organization guidance, 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 Revises Draft Guidance on Certification Process for Medical Gases By Zachary Brennan - Published 24 November 2015

The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer.

Categories: News, US, FDA, Compliance, Distribution, Drugs, Due Diligence, Government affairs, Medical Devices, Quality

Tags: medical gases, FDA guidance, revised draft guidance, oxygen, nitrogen, carbon monoxide