• Regulatory NewsRegulatory News

    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
  • RoundupsRoundups

    FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Exkivity okayed as oral therapy for advanced NSCLC with certain mutations Takeda’s Exkivity (mobocertinib capsules) has been granted accelerated approval as an oral treatment for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as d...
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    FDA guidance covers frequently asked CMC questions for generic drugs

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...
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    Comirnaty booster gets adcomm thumbs up, for limited population

      An advisory committee to the US Food and Drug Administration (FDA) voted 16-2 on Friday against approval of a third booster dose added on to the 2-dose regimen for Pfizer’s COVID-19 vaccine Comirnaty. However, the committee voted unanimously in favor of an emergency use authorization (EUA) for booster doses for those aged 65 years and up, as well as health care workers and other individuals at high risk for COVID-19 because of occupational exposure.   The ball is n...
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    FDA continues data modernization with new Office of Digital Transformation

    The US Food and Drug Administration (FDA) is moving forward in plans to modernize its data and information technology efforts with the launch of a new Office of Digital Transformation (ODT).   “Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said acting FDA commissioner Janet Woodcock, in a Wednesday press release announcing the newest step in its te...
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    In advance of adcomm, Pfizer makes its case for Comirnaty booster

    In briefing documents made available on Wednesday in advance of a US Food and Drug Administration (FDA) meeting, Pfizer made the case that a third dose of its COVID-19 vaccine would address an unmet public health need in the face of high and persistent levels of Delta variant breakthrough infections among the vaccinated.   Pfizer’s application for a supplemental biologics license application (sBLA) for Comirnaty, the messenger RNA (mRNA) COVID-19 vaccine it co-develope...
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    Convergence: Inadequate testing of cell and gene therapies draws FDA concern

    The lack of consistent testing in measuring product quality for cell and gene therapies is a major deficiency found by US Food and Drug Administration (FDA) reviewers in its information requests (IRs) to manufacturers in their submission of biologics license applications (BLAs).   This observation was made by Kedest Tadesse, senior research manager for Agency IQ, which recently compiled a survey of deficiencies identified in IR letters in FDA’s review of five approved ...
  • RoundupsRoundups

    FDA Approvals Roundup: Brukinsa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Brukinsa nabs accelerated approval for previously treated marginal zone lymphoma BeiGene’s Brukinsa (zanubrutinib) has received accelerated approval for expanded use in treating relapsed or refractory  marginal zone lymphoma (MZL) in previously treated adults.   Approval of Brukinsa was based on efficacy findings from two single-arm clin...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...
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    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
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    Marks defends push toward COVID vaccine boosters

    Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), defended the agency's moves toward authorizing third doses of COVID-19 vaccines amid their limited global supply.   Speaking at RAPS Convergence 2021 on Monday, Marks said he is "fully confident" that those who tune into the agency's upcoming advisory committee meeting to discuss Pfizer and BioNTech's supplemental biologics license application (sBLA...