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Meer nieuws en actualiteiten:
- Alternatief nieuwsoverzicht
- Archief Nieuwsbrief voor Goede Onderzoekspraktijken
- Uitgelicht & Gespot op internet
Nieuwsfeed
- For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions
- Emergency IND Timeline
- IND Application Reporting: Safety Reports
- Untitled Letters
- FDA Name Differentiation Project
- Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop - 09/25/2026
- FDA Drug Competition Action Plan
- Forms FDA 3542a and FDA 3542: Questions and Answers
- Newly Added Guidance Documents
- The RW Daily: Science flags paper that found AI chatbots help debunk conspiracy theories. And "Doctor and Staff Charged with Falsifying Data."
- Webpagina’s veiligheidsrapportage voor CTR-studies aangepast
- Ethics on the periphery: Unpacking Ghanaian NGOs’ avoidance of research oversight
- Frequently Requested or Proactively Posted Drug-Specific and Other Records
- Flesh-eating Worms Grab Attention. How Should Attention Affect Policy?
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
- S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
- TEHDAS2 publishes a specification for managing health data access under the EHDS
- TEHDAS2 publishes a guideline to support decision-making on access to health data in the EHDS
- Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/23/2026
- How The Quiet Data Standards Revolution Is Impacting Drug Approval
- Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
- Allergenics Research
- Science flags paper that found AI chatbots help debunk conspiracy theories
- Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024
- Coronavirus (COVID-19) | CBER-Regulated Biologics
- BsUFA IV: Fiscal Years 2028-2032
- Registered Outsourcing Facilities
- Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE) - 07/30/2026
- Meningitis Outbreak: Voriconazole and Liposomal Amphotericin B Availability Information
- Human Drug Compounding Policies and Rules
- Human Drug Compounding Outsourcing Facility Fees
- Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
- Generic Drug Facilities, Sites and Organization Lists
- Generic Drug User Fee Amendments
- ClinicalTrials.gov: Essentials for Academic Medical Centers - 07/14/2026
- The RW Daily: System for flagging retracted papers finds scores of them in Cochrane reviews. And sanctions for misconduct from nothing to prison.
- Euthanasie in cijfers 2025
- ECRIN Newsletter - ICTD 2026 Wrap-up
- Urine Liquid Biopsy Shows Strong Promise for Guiding Bladder Cancer Treatment — Clinical Trials on the Horizon
- New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
- Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026
- FDA notification regarding unapproved drugs included in kits
- What's New Related to Drugs
- Sexual Enhancement and Energy Product Notifications
- Business Pill may be harmful due to hidden drug ingredient
- Branch Manager for Men may be harmful due to hidden drug ingredient
- ELEVIDYS
- Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
- Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension
- NUVAXOVID
