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- FDAOct 13, 2026FDA warning letter: Lovelace Biomedical Research Institute
FDA issued a warning letter to Robert W. Rubin, CEO of Lovelace Biomedical Research Institute, concerning nonclinical studies of investigational drugs. FDA cites inadequate quality assurance review of final reports, including omissions of animal observations and dosing issues recorded in raw data.
Inspections and compliance - FDAOct 13, 2026FDA warning letter: Eurofins SF Analytical Laboratories, Inc.
FDA issued a warning letter to David Riggs, President - EFSA Cluster at Eurofins SF Analytical Laboratories, Inc., about contract microbiological testing of drug components and products. FDA cites incomplete test records, results from damaged plates and gaps in secondary review.
Inspections and compliance - MHRAOct 13, 2026MHRA authorises Onswik (insulin efsitora alfa) for adults with type 2 diabetes
MHRA authorised Onswik (insulin efsitora alfa), a once-weekly basal insulin injection, for adults with type 2 diabetes. The agency reports that clinical trial data showed blood glucose control comparable to once-daily basal insulin treatments.
Approvals and labels - MHRAOct 13, 2026Continuous renal replacement therapy (CRRT): Consider delayed administration of concurrent echinocandins, such as caspofungin, to reduce the risk of adsorption onto new polyacrylonitrile...
MHRA issued device safety information for healthcare professionals managing patients receiving continuous renal replacement therapy. The agency says caspofungin can bind to polyacrylonitrile filter membranes and reduce antifungal effectiveness, with the greatest potential risk when a new membrane or circuit starts.
Safety and recalls - FDAOct 9, 2026Phase 1 Investigational New Drug (IND) Navigator
FDA's Phase 1 IND Navigator brings together resources for sponsors preparing investigational new drug applications for CDER and CBER. The page lists guidance, learning materials, procedures, manufacturing and controls resources, forms and a Phase 1 support team contact.
Regulations and guidanceTrial conduct and operations - FDAOct 9, 2026Phase 1 IND Frequently Asked Questions
FDA provides answers to sponsors' common questions about Phase 1 Investigational New Drug applications. The FAQ covers early trial objectives, supporting nonclinical evidence, submission processes and options for combining phases, with development programmes reviewed individually.
Regulations and guidanceTrial conduct and operations - FDAOct 9, 2026FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus
FDA has approved Hovilpri (pritelivir) for immunocompromised adults with herpes simplex virus lesions that have not responded to specified antiviral therapies. FDA reports that all lesions healed by 28 days in 63% of Hovilpri recipients versus 34% receiving other treatments in the randomized trial.
Approvals and labels - MHRAOct 9, 2026Guidance: MHRA Real-World Evidence: knowledge and guidance
MHRA has published a hub bringing together guidance and resources on real-world data and evidence in UK regulatory decisions for medicines and medical devices. The agency says it is intended for researchers, healthcare professionals, industry, patients and other interested groups.
Regulations and guidanceData, digital and AI - MHRAOct 9, 2026Research: Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs)
MHRA has published resources for developers using patient-reported outcomes in digital mental health technologies. The agency covers evidence generation and routine monitoring, including measure selection, participant burden, safety responses, data access and study reporting.
Data, digital and AITrial conduct and operations - Federal RegisterOct 9, 2026Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of...
Regulations and guidanceTrial conduct and operations - EMAOct 8, 2026Clinical trial applications advice pilot becomes permanent
EMA reports that the ACT EU advice pilot will become permanent from January 2027, continuing technical and regulatory support for sponsors preparing clinical trial applications. The procedure, coordinated by HMA through CTCG, provides feedback from the Member States concerned before submission through CTIS.
Regulations and guidanceTrial conduct and operations - Federal RegisterOct 6, 2026Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information
FDA is seeking public comments on approaches it is considering for early-phase trials of ibogaine drug products. Its request for information concerns trial design and safety considerations for those developing these products.
Regulations and guidanceTrial conduct and operationsSafety and recalls - FDAOct 5, 2026FDA Seeks Public Input to Support Ibogaine Research
FDA announced a request for public input on proposed approaches to early-phase trials of ibogaine drug products, relevant to sponsors developing these medicines. It seeks data and comments on dose selection, eligibility, care settings, safety monitoring, stopping rules and oversight.
Regulations and guidanceTrial conduct and operations - EMAOct 2, 2026Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
EMA reports that its safety committee, PRAC, reviewed safety signals, risk management plans, periodic safety reports and post-authorisation safety studies at its monthly meeting. These assessments concern medicine developers and authorisation holders; no referral procedures were started or concluded.
Safety and recalls - EMAOct 1, 2026Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
EMA has endorsed an ICMRA statement calling on medicine developers, manufacturers, regulators and national control laboratories to advance alternatives to animal testing across the human medicine lifecycle. The statement describes a gradual transition using scientifically valid methods acceptable to regulators.
Public health and policyRegulations and guidance - EMASep 30, 2026Women are missing from medicines development: EMA’s roadmap for change
EMA says it plans to publish a roadmap on medicines for women’s health by the end of 2026, following a workshop that prioritised 10 proposed actions. The proposals involve regulators, researchers, industry and patients, and include better enrolment of women in trials and support for including pregnant and breastfeeding individuals.
Public health and policyTrial conduct and operations