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> EMEA News

 
  • February 12, 2010:

- Form for non-clinical and clinical studies proposed in a PIP application, Human Medicines, Scientific Guidelines - Medicines for children - Guidance for applicants

  • February 10, 2010:

- Draft Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety

- Overview of comments received on draft guideline on the investigation of bioequivalence, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety 

  • February 01, 2010:

- Guideline on Clinical Investigation of Medicinal Products used in the treatment of Osteoarthritis, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety

- Overview of comments received on above draft guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety

- Concept paper on the need for revision of the points to consider on the Clinical Investigation of Medicinal products other than Nsaids in Rheumatoid Arthritis, Human Medicines, Scientific guidelines - Clinical Efficacy & Safety 



> FDA News

  • February 11, 2010:

 - Bioresearch Monitoring Information System Database

  • January 29, 2010: Guidance for Industry

 -  Comprehensive List of Guidance Documents
 - Guidances CDER is Planning to Develop During Calendar Year 2010

  • January 21, 2010:

 - Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies

 

More FDA news:

  - Center for Drug Evaluation and Research News (CDER)

  - Center for Biologics Evaluation and Research News (CBER)

 

>Regulation