Express Pharma

JANUARY 19, 2025

1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. 2024 Jul 27;1842:149129. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318. DOI: 10.1016/j.brainres.2024.149129.

Clinical Pharmacology 111

Clinical Pharmacology Labelling Medical Schools Drug Development 111

FDA Law Blog: Biosimilars

JULY 17, 2024

Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

Putting Patients First Blog

SEPTEMBER 26, 2024

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials (PDF) September 26, 2024 The Honorable Robert M. Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No.

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. On the other hand, CBER provided no additional guidance as to when a clinical endpoint would be appropriate as an intermediate clinical endpoint to support accelerated approval.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59