Whether you work in R&D, Clinical Trials, Submissions, Marketing, Distribution, or Regulatory Affairs, effective medical writing is a must -- particularly when even the smallest of errors can disrupt the product lifecycle. That's why all industry professionals – regardless of role or level – should attend this informative webinar for a back-to-basics overview of "Medical Writing 101."
FDA User Fee Work Continues Following House Passage Bill moves to conference committee with House passage under suspension of the rules, but negotiators will have to reconcile pay-fors and track and trace differences.
As the FDA faces the implementation of new user fee programs, defining evidence standards will solidify the FDA's role in pre- and post-approval evidence generation. How the FDA interprets its evolving authority will have a direct impact on patient access to innovative medical technologies.
Join us for a complimentary webinar on Tuesday, June 5th 10 a.m. PDT to learn how leading Pharma companies such as Allergan, J&J and BMS are leveraging a new generation of cloud-based, domain-specific sales and marketing analytics for superior market insight and action.
After Mea Culpa, Vertex Reiterates Enthusiasm For CF Combo Therapy Program Blaming a mistake in data it presented publically in early May on a "misinterpretation" between itself and an outside vendor, Vertex executives reiterate plans to proceed with a pivotal registration trial for a CF combination therapy.
New Rules From FDA: In a new guidance document, FDA lays groundwork for testing new drugs in early stage, high-risk breast cancer and securing approval with just one pivotal trial. Guidance could dramatically shorten time for drug development.
