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  • Regulatory NewsRegulatory News

    FDA Unveils New Tables for Submitting Bioanalytical Methods

    The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments. “The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic protein...
  • Regulatory NewsRegulatory News

    Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

    • 19 August 2019
    • By  
    Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file (DMF), via the Center for Drug Evaluation and Research (CDER)’s NextGen Portal.   The pre-assigned number requests were previously made via email. But now the firms submitting such applications can use the portal, which is a ...
  • Regulatory NewsRegulatory News

    When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

    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 On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision. Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or ...
  • Regulatory NewsRegulatory News

    FDA's Frey Reflects on Final Year of PDUFA V

    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. Speaking at the FDA/CMS Summit in Washington, D.C. on Tuesday, Frey said that before PDUFA, and during the first four PDUFA programs, FDA was approving ab...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    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. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...
  • Regulatory NewsRegulatory News

    CBER Director Touts Center's FY2016 Performance

    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. The report is Marks' first since he rose to head CBER last January, replacing former CBER Director Karen Midthun after her 22-year stint at the agency. As in previous years, CBER met or e...
  • Regulatory NewsRegulatory News

    Grouping Supplements for CMC Changes: FDA Outlines New Policy

    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. The agency says the goal of its new policy is ...
  • Regulatory NewsRegulatory News

    FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years

    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. As of 30 September 2015, the report says there are 57 programs participating in the biosimilar product development program (up from 33 in FY 2013 and 48 in FY 2014), and a total of seven Biologics L...
  • Regulatory NewsRegulatory News

    FDA Releases Final Guidance on Integrated Summary of Effectiveness

    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). In terms of the changes between the draft and final versions, FDA has revised the definition of integrated analyses, clarified the components that constitute integrated analyses, defined poole...
  • Regulatory NewsRegulatory News

    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    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. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
  • Regulatory NewsRegulatory News

    FDA Finalizes Lot Distribution Report Guidance With Few Changes

    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. Background As required by  21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted...
  • Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes'

    A new Warning Letter from the US Food and Drug Administration (FDA) to North Carolina-based allergy product manufacturer Greer Laboratories claims that the company failed to manufacture an allergenic extract in the manner described in its approved biologics license application (BLA), among other alleged problems. The 21 April 2014 Warning Letter-released to the public on 6 May 2014-references a November 2013 inspection by FDA officials at Greer's Lenoir, NC facility. Th...