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admin has authored 513 entries on this weblog:
- EMA to have debate on the use of epidemiology in the assessment of drug effects
- EMA and FDA Seek Candidate for Joint GMP Inspection Programme
- The FDA, Issues Assessments of the 510(k) Programme and Use of Science in Decision-Making
- EMA THe European Drug Regulator, Publishes CHMP Efficacy Working Party Therapeutic Subgroup on Pharmacokinetics (EWP-PK) Q&A on Positions on Specific Questions Addressed
- Testimonial SkinSecure – Joanne Reed
- EMA, The European Drug Regulator, Publish Overview of Comments Received on “Guideline on the clinical investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder, (ADHD)
- NICE, the UK HMO, Publishes full Guidance on the Diagnosis and Management of Metastatic Malignant Disease of Unknown Primary Origin
- EMA, Publishes Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
- NICE, the UK HMO, Publishes Guidance on Dietary Interventions and physical activity interventions for weight management before, during and after pregnancy
- EMA, The European Drug Regulator Publishes Recommendation on Elements Required to Support the Medical Plausibility and the Assumption of Significant Benefit for an Orphan Designtion
- NICE, the UK, HMO, Publishes Guidance on Percutaneous Radiofrequency Ablation for Renal Cancer
- EMA, The European Drug Regulator, Publishes Centralised Procedures and MRL Procedures Recommended Submission Dates for New and Extension Applications
- NICE, the UK HMO, Publishes Guidance on Percutaneous Mitral Valve Annuloplasty
- EMA, The European Drug Regulator, Publishes Concept Paper on the Revision of the Note for Guidance on the Quality of Modified Release Oral Dosage Forms and Transdermal Dosage Forms: Section I (Quality)
- NICE, The UK HMO, Publishes Guidance on Motor Neurone Disease, the use of Non-Invasive Ventilation
- NICE the UK HMO, Published Guidance on Denosumab for the Treatment of Therapy-Induced Bone Loss in Non-Metastatic Prostate Cancer (terminated appraisal)
- EMA, The European Drug Regulator Publishes Draft Guideline on Setting Specifications for Related Impurities in Antibiotics
- NICE, The UK Regulator Publishes Guidance on Rituximab for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukaemia
- FDA, The USA Drug Regulator, Published Guidance for Industry on Label Comprehension Studies for Non-Prescription Drug Products
- EMA, The European Drug Regulatory, Publish Draft Procedural Advice on the Consultation of Notified Bodies in Accordance with Article 9 of Regulation (EC) No.1394/2007
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