We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
<p style="margin: 0in 0in 10pt;"><span>When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA’s Office of Generic drugs (OGD) was trying to manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times. </span></p>
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.<br />
West is pleased to announce that the AccelTRA™ component program has been recognized with a 2018 India Packaging Award in the category of “Packaging Design in Injectables.” The award was announced during a ceremony at the 2018 InnoPack Pharma Confex in Mumbai, India on May 24, 2018.
Containment/delivery systems for sensitive biologic drugs must provide the chemical, physical, and performance properties required to ensure product quality through shelf life. Further, they must be compatible with fill/finish operations, and enable functional performance during administration. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future biologic drug products.
English
Chinese
