Entries from HEALTH LAW SECTION BLOG tagged with 'international harmonization'

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,...

Public health and IP policy: Amicus briefs in the Bilski case

Questions presented in the recently argued Supreme Court case, Bilski v. Kappos (1), inspired the filing of a large number of Amicus Briefs and in many of them, strong concerns were expressed as to the kinds of potential impacts this...

AERS: a useful tool for FDA

Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here (1) as summary statistics covering data received...

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