Clinical Development Clinical Trials Containment Development 
Advarra
OCTOBER 4, 2023
When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.
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Drug Discovery World
DECEMBER 26, 2023
Neuroscience was also a key area for the year for the audience, with a number of ground-breaking developments, including a new potential treatment for schizophrenia and positive results for psychedelics as an antidepressant. The drug works by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9).
FDA Law Blog
MARCH 7, 2024
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
Pfizer
FEBRUARY 16, 2023
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. FDA in July 2017.
The Pharma Data
NOVEMBER 30, 2020
Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.
Pharmaceutical Technology
FEBRUARY 8, 2023
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.
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