2017 Communication Drug Development 
pharmaphorum
JULY 19, 2022
Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.
Pharmaceutical Technology
FEBRUARY 8, 2023
Since the first approval in 2017, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cell and gene therapies. Despite the challenges that drug developers must overcome to produce gene therapies for rare diseases, Hart underscored the FDA’s intent to encourage more innovation in this space. “We
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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. While many pieces of the drug development process have digitised to keep pace with the speed of technological advancements, clinical trials continue to lag amidst pharma’s digital transformation.
European Pharmaceutical Review
JUNE 24, 2022
But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.
Pharmaceutical Technology
MAY 3, 2023
Moreover, inspections of manufacturing plants outside the US have revealed unsafe practices in the production of some generic drugs which has also exacerbated the problem. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to allow consumers to get access to medicines.
Pharmaceutical Technology
NOVEMBER 30, 2022
A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. The same can be said for the US. of adults were overweight, 42.4% were obese, and 9.2%
Pharmaceutical Technology
NOVEMBER 30, 2022
A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. The same can be said for the US. of adults were overweight, 42.4% were obese, and 9.2%
Expert insights. Personalized for you.
105 
Let's personalize your content