• ReconRecon

    Recon: FDA to get less funding in Senate budget bill for FY 2023 compared to House version; EU funders fail to measure clinical trial transparency

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 ( The Pink Sheet ) ( Senate ) US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas ( The Pink Sheet ) FDA greenlights Marius; oral hypogonadism pill; VBL Therapeutics makes cuts to its workforce ( Endpoints ) Biden Names Monkeypox Coordinator as States ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan

    Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and innovation agenda for the coming year.   One year ago, TGA listed product regulation and safety, regulatory reform, international engagement, and education and compliance as its priorities for 2021 and 2022. Those themes recur in the l...
  • Regulatory NewsRegulatory News

    Califf seeking Congressional assurance user fees won’t run out

    With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get certainty from lawmakers their jobs are not in jeopardy, according to a  letter to FDA employees dated 29 July.   “We are continuing to evaluate the situation, and to explore all potential options and scenarios,” said Califf. “Our latest estimates are that w...
  • Regulatory NewsRegulatory News

    FDA official: Patients play an increasing role in rare disease drug development

    Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US Food and Drug Administration’s (FDA) Office of New Drugs (OND).   “Patients are increasingly recognized by all stakeholders as experts,” Lee said during a webinar on rare disease drug development hosted by the National Organization for Rare Disorders (NORD) on 27...
  • ReconRecon

    Recon: US makes $1.7 billion deal with Moderna for updated Covid booster; Sarepta plans to seek accelerated approval for Duchenne gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US   U.S. Reaches $1.74 Billion Deal With Moderna for Updated Covid-19 Shots ( Wall Street Journal ) ( The Pink Sheet ) ( Reuters ) Sarepta to seek early FDA approval for gene therapy to treat Duchenne muscular dystrophy ( STAT ) ( Fierce ) FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should ‘move into a ne...
  • Regulatory NewsRegulatory News

    FDA clarifies reporting post-approval changes for disposable manufacturing materials

    The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.   The guidance covers changes made to new drug applications (NDAs), biologics license applications (BLAs) or abbreviated new drug applications (ANDAs) and applies to all manufacturing establishments, including those that perform functions under contract.   During the...
  • Feature ArticlesFeature Articles

    A guide to finding the right mentor for regulatory career advancement

    All regulatory professionals share the same goal – to facilitate the commercialization of safe and effective products and services. However, accomplishing that goal and succeeding in this diverse discipline over the course of a career requires that one continuously adapt and pursue professional development opportunities. At an early career level, associates and specialists rely on their analytical skills, assessing technical documentation and practices against established ...
  • Regulatory NewsRegulatory News

    This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, the US Food and Drug Administration (FDA) published a guidance that describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that drug and biological product manufacturers can reference. The agency also publishe...
  • Feature ArticlesFeature Articles

    The mentor-mentee relationship: Surviving remote work

    Mentorship is an important aspect of professional growth. The COVID-19 pandemic disrupted how regulatory professionals interact with colleagues. This article discusses the benefits mentees and mentors gain from mentorship relationships and steps to consider when trying to build a mentor-mentee relationship – in-person or remote. It explores the dynamics of mentorship and its value for advancing a regulatory professional’s career.   Keywords – mentorship, networking,...
  • Regulatory NewsRegulatory News

    FDA blasts US API firm for lax response to mold contamination, data integrity failings

    A US manufacturer of active pharmaceutical ingredients (API) was lambasted in a recent warning letter by the US Food and Drug Administration (FDA) for multiple good manufacturing practice (GMP) violations, one of which was a failure to adequately respond to mold contamination.   The firm also failed to maintain control over its computer systems to prevent unauthorized access to electronic data.   The warning letter was issued on 18 July to St. Louis-based manufactu...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on including patients with incurable cancers in oncology trials

    The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational therapies.   In their guidance, the agency recommended sponsors include patients with incurable cancer—defined as unresectable, locally advanced, or metastatic disease in solid tumors and/or hematologic malignancies with unfavorable long-term overall survival—in oncology clinical trials even if they met criteria ...
  • Regulatory NewsRegulatory News

    FDA proposes checklist to inform patients of LASIK surgery risks

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance on conveying the potential risks with Laser-Assisted In Situ Keratomileusis (LASIK) laser products in labeling to better convey these risks to consumers.   On 27 July, FDA published a draft guidance titled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations . As more potential side-effects of LASIK treatments have become known over the years, the agency hop...