• ReconRecon

    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
  • Regulatory NewsRegulatory News

    FDA updates on ASCA pilot, lists accredited test labs

    In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.   The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medica...
  • Regulatory NewsRegulatory News

    FDA: Master protocols have value in COVID-19, and beyond

    An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits and the risks of potential COVID-19 treatments and outlined ways to ensure the integrity of the data generated from these protocols.   Gregory Levin, the deputy director of the Division of Biometrics III in the FDA’s Office of Biostatistics, described how master protocols can be leveraged to evaluate the safety ...
  • Regulatory NewsRegulatory News

    DIA/FDA Forum: CBER's pandemic journey continues

    Crushing workloads and statistical conundrums characterized the work of FDA’s staff as they raced to formulate guidelines and then evaluate vaccine candidates amid the pressure of the pandemic, attendees at a biostatistics conference heard on Wednesday.   More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines th...
  • Regulatory NewsRegulatory News

    FDA issues long-awaited pandemic remote inspections guidance

    More than a year after the COVID-19 pandemic forced the US Food and Drug Administration (FDA) to halt most on-site inspections, the agency on Wednesday issued guidance detailing its approach to remote interactive evaluations of drug and biomedical research facilities during the public health emergency.   Teleconferencing, livestreaming video and screen-sharing technologies are among the tools FDA says it will use when it determines that a remote interactive evaluation ...
  • RoundupsRoundups

    FDA Approvals Roundup: Trodelvy and Xolair

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Trodelvy approved for advanced triple-negative breast and urothelial cancers Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) has received regular approval for treating unresectable locally advanced or metastatic triple-negative breast cancer ( mTNBC) and accelerated approval for locally advanced or metastatic urothelial cancer ( mUC ), both for ...
  • Regulatory NewsRegulatory News

    FDA’s document-based inspections prompt warning letters for GMP violations

    The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.   The warning letters signal the agency’s increasing reliance on a review of...
  • Regulatory NewsRegulatory News

    ASCO-Friends meeting: NCI offers strategies to modernize cancer trials

    In a conversation hosted by the Friends of Cancer Research and the American Society of Clinical Oncology, cancer researchers spoke with regulators and industry to lay out ways to modernize cancer clinical trial eligibility criteria. Further, advances in use of real-world evidence and remote data collection may eventually reduce reliance on the classical clinical trial, according to some attendees.   During the 9 April webinar, attended by US Food and Drug Administratio...
  • Regulatory NewsRegulatory News

    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
  • Regulatory NewsRegulatory News

    FDA officials address 'complete assessments' at DMF workshop

    The US Food and Drug Administration (FDA) held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially derail the agency’s on-time review of generic drug applications.   The 3-hour webinar covered such topics as fee payments, completeness assessments, impurity assessments, facility identification and selecting starting mater...
  • Regulatory NewsRegulatory News

    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
  • Regulatory NewsRegulatory News

    Cavazzoni named to permanent CDER director role

    Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER).   The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. She was appointed to the position when Janet Woodcock, MD, left to assume her role leading the therapeutics arm of the COVID-19 accelerator Operation Warp Speed (OWS).   “Pleased to announce the perma...