2017 Communication Documentation 
Eye on FDA
AUGUST 10, 2023
Every six months, we do a look-back to see what has changed in the way that FDA is communicating. The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. And there is more to tell.
FDA Law Blog: Biosimilars
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
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Eye on FDA
JANUARY 9, 2022
As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.
Pharmaceutical Technology
FEBRUARY 8, 2023
In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.
pharmaphorum
OCTOBER 20, 2020
While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period. In the US, the trend had already started pre-COVID-19.
pharmaphorum
DECEMBER 6, 2022
Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC.
Putting Patients First Blog
APRIL 30, 2024
Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.
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