Search Results for CMC

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CMC Changes for Biologics: FDA Offers Draft Guidance By Zachary Brennan - Published 21 December 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA).

Categories: News, US, CBER, Biologics and biotechnology, Manufacturing

Tags: FDA draft guidance, CMC changes

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

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

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

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

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

FDA Looks to Standardize PQ/CMC Data and Terminologies By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMC submissions, electronic submissions FDA, PQ/CMC data

Grouping Supplements for CMC Changes: FDA Outlines New Policy By Zachary Brennan - Published 20 April 2016

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, NDA supplements, ANDA supplements, BLA supplements

Postapproval CMC Changes: FDA Updates Guidance By Zachary Brennan - Published 19 April 2016

Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: CMC changes, comparability protocol, CMC postapproval changes

Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial By Raymond Huml, MS, DVM, RAC, Nigel Rulewski, MD, Kamali Chance, MPH, PhD, RAC, Doris Weilert, PhD, J. Rick Turner, PhD - Published 01 March 2016

This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development.

Categories: Features, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars, Clinical development, CMC

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

Which Drug Manufacturing Changes Should be Reported? FDA Explains By Alexander Gaffney, RAC - Published 01 June 2015

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, and how.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: Drug Quality, CMC, Guidance, Draft Guidance

FDA Unveils New Guidance on Reporting Post-Approval Changes Published 04 March 2014

Categories: US, FDA

Tags: CMC

FDA Releases New Veterinary CMC Guidance By Alexander Gaffney - Published 07 March 2012

Categories: Manufacturing

Tags: VMF, DMF, JINAD, ANADA, INAD, CNADA, NADA, Fermanation, FDA. CMC, Chemistry, Veterinary, CVM, Latest News, controls, guidance

Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible By John Geigert, PhD, RAC - Published 06 February 2012

Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; Part 2 examined the major differences between biologics and chemical drugs; and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures in the chemistry, manufacturing and controls (CMC) regulatory strategy for biologics abound: a recombinant enzyme is delayed in gaining market approval because the US Food and Drug Administration (FDA) concludes that "the commercial process is not representative of the Phase 3 material used to establish the safety and efficacy profile; "a recombinant protein is rejected by the European Medicines Agency (EMA) because "with regard to Quality a large number of outstanding issues remained" (e.g., lack of product comparability, insufficient stability data, manufacturing process not adequately validated); a recombinant protein is withdrawn from the US market because a "minor change in the formulation" leads to spontaneous syncope (fainting).

Categories: EMA, FDA, Manufacturing

Tags: Chemistry, Perspective, strategy, controls, Biologics, CMC, risk, regulatory

Demystifying CMC Regulatory Strategy for Biologics - Part 2: Biologics Are Not Chemical Drugs By John Geigert, PhD, RAC - Published 01 November 2011

Senior managers, especially if they have recently moved from the chemical drug side of the business into biologics, may raise the question of whether biologics are really different from chemical drugs or if this is just a perception. As clearly stated by the regulatory authorities, biologics are not chemical drugs and similar biologics are not biogenerics. A glance at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites clearly shows the agencies view biologics and their manufacturing processes as different from chemical drugs.

Categories: EMA, FDA, Manufacturing

Tags: Chemical, Perspective, biologic, Biologics, CMC, regulatory