Search Results for BLA

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When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse to file, NDA, BLA, FDA draft guidance

FDA's Frey Reflects on Final Year of PDUFA V By Michael Mezher - Published 06 December 2017

As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI.

Categories: News, US, CDER, Biologics and biotechnology, Communication, Drugs, Orphan products, Submission and registration

Tags: PDUFA, NDA, BLA, Orphan Drugs, Approvals

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manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.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Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

CBER Director Touts Center's FY2016 Performance By Michael Mezher - Published 06 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: CBER, PDUFA, MDUFA, BLA

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

FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years By Zachary Brennan - Published 14 March 2016

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Compliance, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, FDA work on biosimilars, 351(k), BLA, FDA FTEs

FDA Releases Final Guidance on Integrated Summary of Effectiveness By Zachary Brennan - Published 07 October 2015

More than seven years since unveiling the draft document, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance on how an Integrated Summary of Effectiveness (ISE) should be prepared for new drug applications (NDAs) and biologics license applications (BLAs).

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ISE guidance, BLA, NDA, drug effectiveness, FDA guidance

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years By Alexander Gaffney, RAC - Published 07 May 2015

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: eCTD, Electronic Common Technical Document, NDA, BLA, IND, 505(b)(2), DMF, BPF

FDA Finalizes Lot Distribution Report Guidance With Few Changes By Alexander Gaffney, RAC - Published 20 March 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Postmarket surveillance

Tags: Guidance, Final Guidance, LDR, Lot Distribution Reports, BLA

Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes' By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA

Tags: warning letter, Insect, BLA, Latest News, cGMP

CDRH, CBER Finalize Medical Device Review Communication Guidance By Alexander Gaffney, RAC - Published 03 April 2014

Categories: US, FDA, CBER, CDRH

Tags: Substantive Interactions, Acceptance Review, Interactive Review, BLA, Communication, Latest News, 510(k), PMA, guidance

CBER Finalizes Two Guidance Documents on Use of Hematopoietic Progenitor Cells By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Hematopoietic, Cord Blood, HPC, Minimal Manipulation, Final Guidance, BLA, IND, Latest News, guidance

FDA Finalizes Guidance on Priority Review Process for Medical Devices By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US, FDA

Tags: PDP, BLA, 510(k), PMA

New FDA Guidance Clarifies Process for Submission of Device User Fees By Alexander Gaffney, RF News Editor - Published 04 April 2013

Categories: US, FDA

Tags: FDASIA, BLA, User Fee, MDUFA, Latest News, PMA, guidance, medical device

FDA Publishes New Benefit-Risk Paradigm Framework, Rejects Quantitative-Only Approach By Alexander Gaffney, RF News Editor - Published 06 March 2013

Categories: FDA

Tags: Risk/Benefit, Benefit-risk, framework, Benefit, BLA, Latest News, NDA, risk

FDA Prepares Plan to Conduct 'Exit Interviews' With NDA, BLA Sponsors By Alexander Gaffney, RF News Editor - Published 15 February 2013

Categories: FDA

Tags: BLA, NDA

In Shift, FDA to Require eCTD for all NDA, ANDA, BLA and IND Submissions By Alexander Gaffney, RF News Editor - Published 03 January 2013

Tags: BLA, ANDA, IND, eCTD, NDA

Draft Guidance on Cell, Gene Therapy Products Establishes General Framework By Alexander Gaffney, RF News Editor - Published 29 November 2012

Categories: FDA, Preclinical

Tags: Cell Therapy, CTG, Gene Therapy, BLA, IND, Latest News, draft guidance

Report: FDA Meeting Review Goals Under PDUFA By Alexander Gaffney - Published 01 May 2012

Categories: FDA

Tags: Priority, Review Times, Report, BLA, Standard, Latest News, GAO, Congress, NDA, review, submission, REMS, PDUFA

BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort By Alexander Gaffney - Published 28 March 2012

Categories: FDA

Tags: Rate, Approved, CRL, BIO, BLA, Latest News, pharmaceutical, biologic, approval, NDA, drug

Shire Pulls BLA Submission After FDA Demands More Clinical Trials By Alexander Gaffney - Published 16 March 2012

Tags: Withdrew, Agalsidase Alfa, Replagal, Fabry, Shire, FDA< BLA, Withdraw, application, Latest News, disease

FDA Releases Guidance on Proper Size, Testing of Sprinkled Drug Products By Alexander Gaffney - Published 28 February 2012

Categories: FDA

Tags: Sprinkle, Beads, Sprinkled, BLA, ANDA, Latest News, testing, NDA, guidance

CDER: Guidance on NDA/BLA/ANDA Data Standards Coming in Mid-2012 By Alexander Gaffney - Published 13 January 2012

Categories: FDA, CDER

Tags: BLA, DSP, Data Standards Program, ANDA, 2012, Latest News, NDA, guidance