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LEARN ABOUT THE DRUG AND DEVICE DEVELOPMENT PROCESS

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Sponsored by the Clinical and Translational Science Center (CTSC)

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weill.cornell.edu/ctsc/news/resources/2016_Registration_SpringSeminars.doc

• Drug Development and FDA Regulations… 130 more words

Weill Cornell CTSC

Webinar on Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

Scheduled On : Tuesday, March 15, 2016 at 13:00 Hrs

Description :

The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. 449 more words

Medical Device

What if it were Wheelchairs

Today I read a MedPageToday.com article about experts responding to the new FDA Opiod Action Plan. I won’t take the time to paraphrase the article which contains links to the agency’s statement as well as other insights, but you can access it here: … 694 more words

Medical

Webinar On FDA Compliance and GAMP V Computer System Classification

Scheduled On : Wednesday, January 13, 2016 at 13:00 Hrs 

Description :

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. 382 more words

Life Science

Webinar On FDA's New Enforcement of 21 CFR Part 11

Scheduled On : Wednesday, January 13, 2016 at 13:00 Hrs      

Description :

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. 279 more words

Life Science

Requisitos de la FDA para Exportar Alimentos y Bebidas a los EE.UU.

Únase a Registrar Corp el Martes 27 de octubre de 2015 en el 19ª Americas Food and Beverage Show en Miami, Florida, para aprender cómo exportar alimentos a los EE.UU. 96 more words

2015 AFB Showcase And Conference

Court approves Vascepa® for off-label use despite pushback from FDA

On Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). 474 more words

Property & Casualty