With this updated two-day program, you learn the fundamentals of the laws and regulations that affect all Food and Drug Administration (FDA)-regulated products: food, drugs, biologics, medical devi...read more
This two-part, national conference offers the following sessions on Personalized Medicine:
Anticipating Personalized Medicine: A Roundtable Discussion
Predictions about the future course of medi...read more
Webinar Series : Session #1
Title VIII – Clinical Trial Databases: A Status Report on Implementation
June 17, 2008 The Food and Drug Administration Amendments Act (FDAAA) requires the res...read more
This CD was recorded in November 2007.
On October 4, FDA outlined a program aimed at increasing the number and var...read more
This CD was recorded in July 2007.
Winning FDA approval of a preferred brand name for a new drug or biologic is an important regulatory and marketing step for manufacturers, but it’s ...read more
FDA issued a draft Guidance for Industry titled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Use...read more
This CD was recorded in September 2006.
A panel of experts discuss some of the latest issues facing the Center for Devices and Radiological Health (CDRH) and the regulated industry in ensuring co...read more