OPS/OC/ONDQA/OGD - NIHS
OPS/OC/ONDQA/OGD - NIHS
OPS/OC/ONDQA/OGD - NIHS
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添 付 資 料 4-b FDA 後 発 医 薬 品 審 査 と 米 国 薬 局 方<br />
Impact of USP Monographs<br />
on the<br />
Ollice of Generic Drugs<br />
Review Process<br />
October 1,2007<br />
Frsnk O. Holcombe, Jr.' Ph.D.<br />
Associate Director for Chemistry<br />
Ollice of Generic Drugs<br />
USP/I\F<br />
United States Pharmacopeial Convention<br />
. Promote Public Health Through Authoritative<br />
Standards and Information<br />
. United States Pharmacopeia and National<br />
Formulara<br />
. Independent<br />
. Public Process<br />
. Non-Governmental