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. And the increase in profile of Spanish releases would also be higher when there are fewer press releases if the number of bilingual communications remained the same. Overall, there have been shifts in the way the agency is communicating.

Communication 80

Communication Documentation 80

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 88

Documentation Communication 88

pharmaphorum

AUGUST 30, 2022

The importance of patient and public involvement and engagement (PPIE) has been well documented, but there has, to date, been a lack of practical advice on how to implement and manage meaningful processes. . The result was the EnACT (engage, acknowledge, communicate, and trust and transparency) principles, as set out in the guide: .

Communication 82

Communication Documentation 82

pharmaphorum

FEBRUARY 2, 2022

Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”. A practical consensus. Everything has moved so quickly.

Documentation 52

Documentation Packaging Communication 52

Putting Patients First Blog

FEBRUARY 6, 2024

Innovation in drug research and development for prevalent chronic diseases: proceedings of a workshop. Nature Communications, 11(6265). Translational Medicine Communications, 4(18). autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L.,

Communication 40

Communication Documentation Drug Development 40

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.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52