May 28, 2013
28 May 2013
FDA has published new draft guidelines for contract manufacturing for
drugs...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf
There will two public meeting on Risk Evaluation and Mitigation
Strategies for drugs and biologics this July in Silver Spring,
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm351029.htm
The tentative meeting schedule of FDA Advisory Committees has been
published? http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm
Health Canada is recommending a series of changes to its Recognized
Standards list?
www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/md_stand_im_draft_ebauche_norm_prop_lst-eng.php
Judy Develin, Head of Australian TGA's Market Authorisation Group gave
a presentation at AusMed Tech Conference on the future of the TGA?
http://www.tga.gov.au/newsroom/events-presentations-ausmed-130516.htm
Speaking of goings on down under, the TGA has also been updating their
Code for Human Blood and Tissues?
http://www.tga.gov.au/industry/manuf-cgmp-human-blood-tissues-revised.htm
The TGA is also looking for new members for their advisory committees?
http://www.tga.gov.au/about/committees-expert-vacancies.htm
FDA has published new draft guidelines for contract manufacturing for
drugs...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf
There will two public meeting on Risk Evaluation and Mitigation
Strategies for drugs and biologics this July in Silver Spring,
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm351029.htm
The tentative meeting schedule of FDA Advisory Committees has been
published? http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm
Health Canada is recommending a series of changes to its Recognized
Standards list?
www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/md_stand_im_draft_ebauche_norm_prop_lst-eng.php
Judy Develin, Head of Australian TGA's Market Authorisation Group gave
a presentation at AusMed Tech Conference on the future of the TGA?
http://www.tga.gov.au/newsroom/events-presentations-ausmed-130516.htm
Speaking of goings on down under, the TGA has also been updating their
Code for Human Blood and Tissues?
http://www.tga.gov.au/industry/manuf-cgmp-human-blood-tissues-revised.htm
The TGA is also looking for new members for their advisory committees?
http://www.tga.gov.au/about/committees-expert-vacancies.htm