• Regulatory NewsRegulatory News

    FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages

    The US Food and Drug Administration’s FY 2022 budget request to Congress indicates the agency’s wishes to catch up on the backlog of inspections that have been delayed due to COVID-19, improve its drug surveillance efforts to detect possible shortages, and avert shortages for such medical devices as personal protective equipment (PPE).   Many of these requests have been driven by the need to combat device and drug shortages wrought by the pandemic.   The request al...
  • Regulatory NewsRegulatory News

    Smallpox antiviral approved under FDA’s Animal Rule

    Though the World Health Organization declared smallpox eradicated in 1980, FDA has approved Tembexa (Chimerix,brincidofovir) as a treatment for the contagious, deadly disease caused by the variola virus.   The 4 June announcement of Tembexa’s approval noted that smallpox drug development is “an important component of the US medical countermeasures response,” since the federal government has significant concerns about the virus’ potential use as a bioweapon. Tembexa was...
  • Regulatory NewsRegulatory News

    FDA approves aducanumab for use in Alzheimer’s disease

    The U.S. Food and Drug Administration (FDA) on Monday announced the approval of Biogen’s human monoclonal antibody Aduhelm (aducanumab) for use in patients with Alzheimer’s disease under the agency’s accelerated approval pathway.   FDA’s approval of aducanumab is based on results from two Phase 3 clinical trials of patients with early Alzheimer’s disease (AD), EMERGE and ENGAGE . Both trials were stopped in March 2019 due to apparent futility by a data safety monito...
  • Regulatory NewsRegulatory News

    FDA details plans for DSCSA implementation in four guidances

    The US Food and Drug Administration (FDA) on 3 June released four guidances on its plans for implementing the Drug Supply Chain Security Act (DSCSA), setting the agency’s expectations for how pharmaceutical manufacturers should comply with new product tracing requirements.   They address situations that can increase the risk of suspect products entering the supply chain, expectations for product identifiers, interoperable electronic tracing of products and definition...
  • Regulatory NewsRegulatory News

    FDA issues new MAPP on reviewing color additives

    The US Food and Drug Administration’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for reviewing color additives and flavors in new drug applications, supplements, and Type IV drug master files and how these reviews will be coordinated with the Office of New Drugs (OND).   The 12-page MAPP identifies the responsibilities of quality assessors in conducting these reviews and addre...
  • Regulatory NewsRegulatory News

    BsUFA talks progress on supplements, meetings and guidance development

    In the latest round of negotiations between the US Food and Drug Administration (FDA) and the pharmaceutical industry on the reauthorization of the Biosimilar User Fee Amendments (BsUFA), the two sides reached common ground on several topics, including supplements and labeling for product safety updates, meeting management and application review practices.   FDA and industry began negotiations on the third BsUFA program in March following a public kickoff meeting las...
  • Regulatory NewsRegulatory News

    Italian firm falsified sterilization data, FDA warns device firms

    An Italian firm that processes medical devices has been falsifying data, including information related to sterilization certificates, since 2016, according to the US Food and Drug Administration (FDA).   As many as 97 different medical device manufacturers may be affected, wrote FDA’s director of the Office of Product Evaluation and Quality for the Center for Devices and Radiological Health (CDRH), William Maisel, in a letter to medical device manufacturers. He wrote...
  • Regulatory NewsRegulatory News

    FDA provides draft guidance for enteral tube-administered drugs

    A new draft guidance from the US Food and Drug Administration (FDA) gives recommendations for how to test oral drug products’ suitability for enteral feeding tube administration.   Oral solutions are specifically excluded from the guidance, which identifies best practices for “consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube,” according to the Federal Register notice of the availability of the d...
  • RoundupsRoundups

    FDA Approvals Roundup: Pylarify, Lybalvi, Lumakras

    New approvals Pylarify cleared for PSMA-targeted PET imaging in prostate cancer Progenics’ Pylarify (piflufolastat F 18 injection) has been approved for use in positron emission tomography (PET) imaging of prostate-specific membrane antigen‒positive lesions in men with prostate cancer with suspected metastasis or recurrence.   The approval of Pylarify, a radioactive diagnostic agent, was based on safety and efficacy findings from the OSPREY and CONDOR t...
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    FDA authorizes new device to help diagnose pediatric autism

    The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.   The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.   ...
  • Regulatory NewsRegulatory News

    Biden’s first budget request seeks $6.5 billion for FDA

    The US Food and Drug Administration (FDA) is seeking $6.5 billion in funding for FY2022 under President Joe Biden’s $6 trillion budget proposal announced on Friday, an overall increase of $477 million (8%) over the agency’s FY2021 budget.   In a news release, the agency said the $6.5 billion budget would be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which ...
  • RF Quarterly

    Synthetic data and the innovation, assessment, and regulation of AI medical devices

    Synthetic data are artificial data that mimic the properties of and relationships in real data. They show promise for facilitating data access, validation, and benchmarking, addressing missing data and under-sampling, sample boosting, and the creation of control arms in clinical trials. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is using its current research into the development of high-fidelity synthetic data to develop its regulatory position on ar...