Alta Sciences

OCTOBER 30, 2023

TOP RESEARCH SUPPORT SERVICES Video : The Benefits of Conducting a Clinical Trial in Canada Gain valuable insights into Health Canada's Clinical Trial Application (CTA) submission and review process, along with answers to some of your most common questions. Read or listen now. Listen here. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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

DECEMBER 11, 2023

The data used to generate a control arm may be derived from prior clinical trial data (individual or pooled), or observational, real-world data (RWD), such as from registries, electronic health records (EHRs), and medical or pharmacy claims.

FDA 40

FDA Science Clinical Trials Trials 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