Update – February 2014
- Many patients pick unapproved cancer therapies_ Your Say.pdf
- ORA20138 FDASIA 707 Guidance FINAL- July 12 2013-508.pdf
- Presentation-OC Reorg presentation — 1-21-14.pdf
- Providing Reg Submissions in Elec Format Under Section 745 A(a) February 2014.pdf
- Providing Reg Submissions in Electronic Format Stdzed Study Data 5Feb2014.pdf
- 2014-2/Swiss_GLP_Q&A.pdf
Update – January 2013
Previous Updates
- Annex_2_Qualification_of_GC_equipment.pdf
- Annex_3_Qualification_of_UV_Visible_spectrophotometers.pdf
- Annex_4_Qualification_of_IR_spectrophotometers.pdf
- NEW_Annex_1_Validation_of_computerised_calculation.pdf
- NEW_Annex_2_Validation_of_Databases_DB_Laboratory_.pdf
- NEW_Annex_3_Validation_of_computers_as_part_of_tes.pdf
- NEW_Annex_7_Qualification_of_mass_spectrometers.pdf
- UPDATED_Annex_1_Qualification_of_HPLC_Equipment.pdf
- UPDATED_Qualification_of_Equipment_core_document.pdf
- Validation_of_Computerised_Systems_Core_Document.pdf
- April 2012 Update
- UConn researcher fabricated data, investigation finds – January 2012
- Merry Christmas and Regulatory Update
- REGULATORY UPDATE 5/2011
- Regulatory Update – SQA meeting, March 2011
- Regulatory Update 10/2010
- Society of Quality Assurance Update – meeting notes April 26-30, 2010