Documentation Labelling Webinar 
pharmaphorum
OCTOBER 27, 2022
Webinars – Webinars, whether live streamed or on-demand, can be used for communication with HCPs, HCOs, and POs. A company is responsible for the content of webinars and should take reasonable steps to ensure the audience is targeted and well defined.
Eye on FDA
JULY 7, 2020
The interesting thing in connection with that is that in May – in the midst of the COVID-19 pandemic – FDA held a Webinar on the “ Bad Ad” Program – a program that deputizes healthcare professionals to assess promotional communications and report potential violations to the agency.
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FDA Law Blog: Biosimilars
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
Putting Patients First Blog
JULY 2, 2024
Clarify What Information is Sought from Speakers Report on Data Utilization Host Educational Webinars Before Listening Sessions Market as Stakeholder Listening Sessions if They Have Broader Representation Improve the Structure of the Listening Sessions. Finally, we encourage CMS to consider a longer time horizon for the submission of data.
Safe Biologics
MAY 10, 2024
From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”. 1 and go into effect in 2026.
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