Clinical Pharmacology Drugs Trials 
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
Drug Target Review
JULY 4, 2023
Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.
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Cytel
OCTOBER 27, 2023
Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. The key paradigm shift includes:
Alta Sciences
FEBRUARY 8, 2024
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.
FDA Law Blog: Drug Discovery
JULY 17, 2024
An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.
Drug Target Review
AUGUST 7, 2024
This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork.
Eye on FDA
AUGUST 4, 2021
As more drugs are being approved, is FDA getting less advice than in the past? Within those focused on human drugs , there are 17 committees organized under therapeutic categories (Arthritis, Cardiovascular and Renal, Gastrointestinal, e.g.). Fewer meetings – more approvals. If they did want to hold more, are they ready?
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