• Regulatory NewsRegulatory News

    Comments: Affordability and education are key issues in naloxone OTC move

    The US Food and Drug Administration’s recent preliminary assessment that some naloxone products are safe and effective for over-the-counter (OTC) use received overwhelming support in public comments, but stakeholders also raised concerns about affordability, end-user education and the need to include products delivered via intramuscular injection. In November 2022, FDA published a preliminary assessment that nasal sprays that deliver up to 4 mg of naloxone, as well as i...
  • ReconRecon

    Recon: FDA proposes annual COVID shots; Takeda pledges up to $1.13B for Hutchmed’s fruquintinib

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA scientists propose an annual Covid shot matched to current strains ( STAT ) ( Reuters ) With TheracosBio green light, another SGLT2 wades into diabetes arena ( Fierce ) Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal ( Pink Sheet ) FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’...
  • Regulatory NewsRegulatory News

    FDA final rule reduces radiological devices reporting requirements

    The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will substantially reduce the administrative burdens for itself and the medical device industry.   Following a public consultation, FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedu...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more

    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, Ranking Member of the House Energy & Commerce Committee Frank Pallone (D-NJ) wrote to FDA Commissioner Robert Califf and Lawrence Tabak, acting director of the National Institutes of Health (NIH), urging greater enforcement of clinical trial results reporting in ClinicalTria...
  • Regulatory NewsRegulatory News

    FDA issues draft guidance on mpox drug development

    In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule, which enables the agency to approve products without human clinical trials in limited circumstances.   The agency also said that sponsors should talk to regulators early to discuss appropriate clinical trial designs and metrics to prove safety and efficacy. The guidance ...
  • Regulatory NewsRegulatory News

    FDA officials impart lessons learned from quality management maturity pilots

    The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...
  • Regulatory NewsRegulatory News

    Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing

    US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but said it could be improved by incorporating continuous manufacturing principles and clarifying materials testing recommendations.   These comments were made in response to FDA’s release of the Q5A(R2) guideline for public comment in November 2022. The deadline for comments was 13 January....
  • RoundupsRoundups

    Euro Roundup: Swissmedic responds to EU paper on avoiding medical device supply disruptions

    The Swiss Agency for Therapeutic Products (Swissmedic) has detailed its response to the European Union solution for a problem that could disrupt the supply of medical devices in the region.   Last year, the EU Medical Device Coordination Group published a paper, MDCG 2022-18, describing the powers that authorities have to allow the continued sale of products that lack certification. The powers apply if a company’s certificate under the old directive expires before it h...
  • ReconRecon

    Recon: FDA urges federal judge to reject Texas lawsuit challenging abortion pill; EU, Israeli regulators find no stroke signal with Pfizer COVID shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA argues public harm if court reverses abortion pill approval ( The Hill ) ( Endpoints ) ( Bloomberg ) ( Fierce ) Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs ( Endpoints ) ( Fierce ) Diversity in Clinical Trials as FDA Gets a Boost From New Law ( Bloomberg ) FDA’s Novel Approvals Again Led By Oncology And Neurology, But D...
  • Regulatory NewsRegulatory News

    OIG report highlights shortcomings in FDA’s IT acquisition procedures

    Editor's note: This article has been updated with additional comments from the FDA. The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency determined that FDA followed federal regulations, but there were several areas where it failed to assign responsibilities and keep records properly.   ...
  • Regulatory NewsRegulatory News

    Advocacy groups, AdvaMed vie for next phase of TAP pilot

    Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA) pilot program that aims to shorten the time it takes novel devices to reach patients, a nonprofit advocacy group told the agency. The industry lobby group AdvaMed meanwhile called on the agency to select an office with limited experience with the Breakthrough Devices Program.   In comments submitted to the agency, the American ...
  • RAPSRAPS' Latest

    Why Kim Young joined the RAPS’ staff and why she wants you to email her

    Since she first got involved with RAPS in the mid-1990s, Kim Young has been a mainstay among our organization’s rapidly growing European membership. In October 2022, Kim joined RAPS as its first full-time European employee. As our Regional Engagement Director in Europe, Kim won’t just be on the ground at RAPS’ European events . She’ll also be around virtually to help chapters, local networking groups and members get the most out of their RAPS memberships — and to ...