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Patent Law

: Patent Docs

FDA Boot Camp Conference

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

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American Conference Institute (ACI) will be holding its fall session of the FDA Boot Camp conference on September 15-16, 2009 in Boston, MA. The conference will provide information on: ? The organization, jurisdiction, functions, and operations of the FDA; ? The essentials of the approval process for drugs, biologics, and devices, including: NDAs, 505b2s, INDs, 510 K submissions, BLAs, MPA process, and ANDA applications; ? Clinical trials for drugs and biologics and the clearance process for devices; ? The classification of devices and the concept of "risk-based" classification; ? The role of the Hatch-Waxman Act in the patenting of drugs...

Full post as published by Patent Docs on July 11, 2009 (boomark / email).

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