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    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...
  • CDRH, CBER Finalize Medical Device Review Communication Guidance

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions. Those submissions include premarket applications (PMAs), PMA supplements, biologic license applications (BLAs), BLA supplements and premarket notifications [510(k)s]. Background The guidance is intended to reflect changes undertaken by the agency under two pieces of legi...
  • CBER Finalizes Two Guidance Documents on Use of Hematopoietic Progenitor Cells

    Two new guidance documents just released by the US Food and Drug Administration (FDA) finalize recommendations for Biologics License Applications (BLAs) and Investigational New Drug Applications (INDs) submitted in support of minimally manipulated placental or umbilical cord blood intended to help treat patients with hematopoietic system disorders. Hematopoeietic system disorders include ones affecting red blood cells (e.g. anemia), granulocytes (e.g. granulocytopenia), ...
  • FDA Finalizes Guidance on Priority Review Process for Medical Devices

    Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document, this one regarding the priority review of premarket application (PMA) and premarket notification (510(k)) submissions to the agency. Background FDA has several programs it uses to accelerate the approval process for medical products. On the pharmaceutical side, it has fast...
  • New FDA Guidance Clarifies Process for Submission of Device User Fees

    A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user fees to the agency in return for the processing of their premarket approval (PMA) applications and device biologics license applications (BLAs). Background In July 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA) , which, among other ...
  • FDA Publishes New Benefit-Risk Paradigm Framework, Rejects Quantitative-Only Approach

    The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only approach to regulation as counterproductive to its goals to make the decision-making process as clear and predictable as possible. Background The plan, published on 5 March 2013, notes that FDA's mission calls for it to approve drugs that are both safe and effective. But the ...
  • FDA Prepares Plan to Conduct 'Exit Interviews' With NDA, BLA Sponsors

    Exit interviews have long been a tactic of companies looking to collect and understand the opinions of staff, usually when they depart. But now a similar tactic is being proposed by the US Food and Drug Administration (FDA) under the terms of recently passed legislation that would allow an entity acting on its behalf to assess the views of some sponsors of innovative products. Background Under the terms of the fifth iteration of the Prescription Drug User Fee Act (PDUFA...
  • In Shift, FDA to Require eCTD for all NDA, ANDA, BLA and IND Submissions

    • 03 January 2013
    A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been released by the US Food and Drug Administration (FDA). The 3 January 2012 release of the document, Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using ...
  • Draft Guidance on Cell, Gene Therapy Products Establishes General Framework

    The US Food and Drug Administration (FDA) has release a new draft document aimed at providing guidance on the preclinical assessment of cellular, tissue and gene (CTG) therapy products. CTGs are essentially used to make therapeutic changes to a person's cells, tissue or genes by injecting a patient with altered DNA, cells or implanted with organs. The products include cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation and other drug products, i...
  • Report: FDA Meeting Review Goals Under PDUFA

    The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA) . GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) recei...
  • BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...