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532 stories matching this filter · ← front page

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  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • FDA launches pilot program to speed early-phase drug trials
    The U.S. Food and Drug Administration announced a new pilot program aimed at accelerating the review of Phase 1 clinical trials for investigational new drugs. The initiative introduces a rolling s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Experts urge FDA to establish safety and access guidelines for psychedelic drugs; GSK to close German vaccine plant
    Experts are urging the U.S. Food and Drug Administration to set clear safety and access standards for psychedelic medicines, according to the briefing. The request reflects growing interest in the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 1mo agoRegulatoryNegative↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Danone USA recalls So Delicious Dairy Free Salted Caramel Cluster frozen dessert pints over possible foreign material
    Danone USA announced a voluntary recall of its So Delicious Dairy Free Salted Caramel Cluster non-dairy frozen dessert pints. The recall applies to pints with best‑by dates on or before April 3, 2…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • A&P Creations recalls X10 supplement after discovering undeclared Viagra and Cialis ingredients
    A&P Creations LLC announced a voluntary recall of its X10 Natural Enhancement Supplement after testing revealed the presence of sildenafil and tadalafil, the active ingredients in prescription drug…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source
  • Singapore moves forward with legislation for a more coherent, future-ready healthcare regulatory system
    Singapore's Parliament has taken a step toward overhauling its healthcare regulatory framework by advancing new legislation. The proposed law aims to create a more coherent and future-ready system…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Wakefern recalls select organic unsweetened apple sauce jars over high patulin levels
    Wakefern Food Corp announced a voluntary recall of certain containers of its Wholesome Pantry Organic Unsweetened Apple Sauce after FDA testing found patulin levels above safety limits. Patulin is…
    fda recalls · 1mo agoCRLNegative↗ source
  • A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil
    Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restrict…
    fda recalls · 1mo ago↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Evergreen Fresh Sprouts recalls 215 cases of broccoli sprouts over possible Salmonella contamination
    Evergreen Fresh Sprouts LLC of Moyie Springs, Idaho announced a recall of 215 cases of its broccoli sprouts due to potential Salmonella contamination. The product, packaged in 4‑oz zip‑lock bags,…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 1mo agoRegulatoryNeutral↗ source