Entries from HEALTH LAW SECTION BLOG tagged with 'ICH'

Post meeting Update: FDA's modernizing of pharmaceutical regulatory processes-change to keep pace with new realities, ICH up date

Update: Of interest here is the subject matter characterized as Facilitating Innovation for Better Health Outcomes and how using a QbD approach can help make medicinal drug products be more affordable and safe, recurring themes. The importance of team work...

Gene Therapy update

American Society of Gene & Cell Therapy (ASGCT) 2009-2010 President Ken Cornetta presents up to date membership concerns in his recent Editorial about the ASGCT mission of moving gene and cell technologies into clinical practice, (1) observing that: Clearly,...

FDA Steering Committee/Expert Working Groups for ICH on Quality, Safety, Efficacy, Electronic Standards

International Conference on Harmonization (ICH) Public Meeting October 21, 2008, Rockville MD FDA announced a public meeting entitled “Preparation for ICH meetings in Brussels, Belgium” to provide information and receive comments on the ICH as well as the upcoming meetings...

FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.

From CDER email news today: In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed...

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