Blog Clinical Development Clinical Research 
FDA Law Blog: Drug Discovery
NOVEMBER 10, 2024
The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development. The rest of this blog will focus on the Clinical Trials Grants Program.
The Premier Consulting Blog
NOVEMBER 20, 2023
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Molecule Blog
MARCH 17, 2023
This phase is typically executed by private biotech labs and/or contract research organizations, funded by venture capital and/or pharma balance sheets. Once an experimental medicine has undergone all clinical development phases, the company files a new drug application ( NDA — or MAA ), which can be approved or denied by the FDA (or EMA).
The Premier Consulting Blog
JUNE 18, 2023
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. As a direct consequence, in silico methods in human clinical trials are emerging as an important new paradigm in the development of medical therapies – particularly useful for rare diseases.
FDA Law Blog: Drug Discovery
JULY 9, 2024
FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.
PerkinElmer
JANUARY 25, 2023
To help make more timely and informed clinical candidate decisions going forward, scientists need to be able to securely, intuitively, and quickly find, analyze and share critical discovery-stage data, as well as do reliable predictive analysis. These same challenges and needs also extend from research and discovery to clinical development.
Conversations in Drug Development Trends
MAY 30, 2024
Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. As we continue to explore current treatments and venture into new avenues of research, there lies hope for those affected by ALS.
Expert insights. Personalized for you.
69 
Let's personalize your content