pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .

Labelling 128

Labelling Communication Drug Development 128

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Pulses

AUGUST 31, 2023

Table 1: Virtual Technology Platform: Pros and Cons Pros AR VR MR XR Metaverse Enhanced user experience/interaction √ √ Immersive and Engaging Experience √ √ Increased Collaboration and Communication √ √ √ Social interaction √ √ √ √ √ Used in training and simulation √ √ √ √ Enhanced Connectivity √ Creative Expression √ Cons Cybersickness AR VR MR XR (..)

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Labelling 78

Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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Communication Drug Development Packaging Labelling 40

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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Packaging Documentation Labelling Communication 59

Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52