Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Alta Sciences

JULY 31, 2024

Why Diversity in Clinical Trials Matters A wide variety of factors, from age or biological sex to environmental conditions and lifestyle choices (e.g., This minimizes the variability in data when a study goes hybrid and improves compliance and quality of data.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52