Farmas USA

Nuestro Framus ya es Top Ten!! Eres el boss!

El fast track es un pelotazo!
Por lo que veo no se sustituyen fases de forma inmediata pero se acortan los tiempos de 10 meses a 6, y en 2011 el 80% de los fast track se resolvieron para bien o para mal antes de 60días. La comunicación con la FDA es tan estrecha que se pueden suprimir fases pero eso claro está depende de los datos intermedios.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA

An FDA decision not to grant Fast Track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency’s procedures for internal review or dispute resolution if necessary.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

http://www.google.es/url?sa=t&rct=j&q=&esrc=s&source=web&cd=7&ved=0CGIQFjAG&url=http%3A%2F%2Fresources.rhoworld.com%2FPortals%2F161293%2Fdocs%2FAccelerated_Approvals_FINAL.pdf&ei=Xd5RVLSKEpLYapfGgcgN&usg=AFQjCNHa0l4svoyXN4r2Jx0Yy6Wf6M-x3Q&bvm=bv.78597519,d.d2s&cad=rja

coño, nueva coronita. Pero si le prometi a mi mujer el año pasado tras el adcom de Amarin que volveria a la coronita de los 100 ... uy cuando vea un cero menos ...

gracias! ese white paper me lo guardo!

¡¡FELICIDADES!! Muy merecida la tienes :))

JLEON, creo que tu eres de los que la llevan mas barata aqui, 3,7-3,8 verdad?

NVAX

3,78, pero muy pocos cromos....es mas la alegria que los dolares...
:(

oye, la alegria es impagable :)