FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Packaging Documentation Labelling Communication 59

pharmaphorum

OCTOBER 28, 2020

Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. PE isn’t traditional ‘communications’ where organisations talk to try and change patient behaviours, rather it’s about listening to patients to change corporate behaviours.

Vaccines 119

Vaccines Hospitals Pharmaceutical Companies Pharmaceutical Companies 119

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Documentation Adverse Reactions Communication Drug Development 105

Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. 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.,

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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

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.

Documentation 105

Documentation Drug Development Communication 105

pharmaphorum

SEPTEMBER 6, 2021

Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies. Many practitioners have expressed the feeling that EHRs cause far too much of their time ultimately being spent on data entry.

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Medical Records Health and Personal Care Stores Data Entry Hospitals 143

Putting Patients First Blog

APRIL 14, 2023

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. He is reachable via e- mail at egascho@nhcouncil.org.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

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.

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Data Entry Communication Hospitals Documentation 98

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The contents of the document are currently non-binding, but once finalised will represent the current thinking of the agency.

Drug Development 52

Drug Development Documentation Communication 52

Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). However, additional initiatives that de-risk the development process are still needed, says Ruiz.

Drug Development 52

Drug Development Documentation Communication 52

Pharmaceutical Technology

APRIL 24, 2023

Artificial intelligence (AI) is set to be the most disruptive emerging technology in drug development in 2023, unlocking advanced analytics, enabling automation, and increasing speed across the clinical trial value chain. AI can then facilitate the analysis of data and develop all of the required tables, listings and figures (TLFs).

Documentation 52

Documentation Medical Records Communication Drug Development 52

Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Precision Medicine: Streamlining Treatments and Drug Development. Free Whitepaper. Please check your email to download the Whitepaper.

Packaging 52

Packaging Hospitals Medical Schools Documentation 52

Pharmaceutical Technology

APRIL 27, 2023

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market. Please check your email to download the Whitepaper.

Vaccines 52

Vaccines Drug Development Documentation Communication 52