Search Results for NDA

Showing 1 – 25  of 27

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 New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017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 On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.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Tags: refuse to file, NDA, BLA, FDA draft guidance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

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 Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial By Zachary Brennan - Published 11 April 2016

More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval.

Categories: News, Europe, US, EMA, FDA, Clinical, Compliance, Crisis management, Drugs, Postmarket surveillance

Tags: accelerated approval, NDA withdrawn, EMD Serono, Luveris

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: More Than 3.4 Million Hours Spent Each Year Filing New and Generic Drug Applications By Alexander Gaffney, RAC - Published 24 March 2014

Categories: US, FDA

Tags: ANDA, application, Latest News, pharmaceutical, NDA, drug, submission

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA

Tags: NDA Supplement, BA/BE, Regulatory Explainer, BA, Bioavailability, BE, IND, Latest News, pharmaceutical, bioequivalence, draft guidance, NDA

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

New Brain Hemorrhage Treatment Intended as Improvement Over Existing Risky One By Alexander Gaffney, RF News Editor - Published 15 May 2013

Categories: US, FDA

Tags: Approved, approval, NDA

GSK's new COPD Therapy Wins FDA Approval By Alexander Gaffney, RF News Editor - Published 10 May 2013

Categories: US, FDA

Tags: GSK, approval, NDA

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

FDA Approves Thalidomide Analog to Treat Multiple Myeloma By Alexander Gaffney, RF News Editor - Published 11 February 2013

Categories: FDA

Tags: Multiple Myeloma, approval, 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

FDA Grants Accelerated Approval to Leukemia Drug By Alexander Gaffney - Published 10 August 2012

Categories: FDA, CDER

Tags: Talon, Marqibo, ALL, Latest News, orphan drug, NDA

FDA Approves Astellas' Bladder Control Drug By Alexander Gaffney - Published 29 June 2012

Categories: FDA

Tags: Overactive Bladder, Myrbetriq, Astellas, Latest News, approval, NDA

US Regulators Approve First Obesity Drug in 13 Years By Alexander Gaffney - Published 28 June 2012

Categories: FDA

Tags: ANti-Obesity, Belviq, Obesity, Approved, Arena, Latest News, pharmaceutical, NDA, drug

FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products By Alexander Gaffney - Published 21 May 2012

Categories: FDA

Tags: FDA Form 2657, National Drug Code, NDC, ANDA, Latest News, pharmaceutical, NDA, drug

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

Owe FDA Money? Don't Bother Submitting an Application, Says CDER By Alexander Gaffney - Published 19 April 2012

Categories: FDA, CDER

Tags: Owed, Arrears, Money, MAPP, debt, User Fees, ANDA, User Fee, application, Latest News, NDA, submission

AIDS Group Calls for Hamburg's Resignation By Alexander Gaffney - Published 28 March 2012

Categories: FDA

Tags: Resignation, AHF, AIDS, PrEP, HIV, Latest News, Hamburg, approval, NDA

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

Health Canada Accelerating Approvals to Ease Drug Shortages By Alexander Gaffney - Published 19 March 2012

Categories: Canada, Health Canada

Tags: Fire, Sandoz, Latest News, Drug Shortages, NDA, review

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