Metabolite Tales Blog

JULY 5, 2023

APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. The two sides saw nearly every finding in a different light.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

Regulations 40

Regulations FDA Science Production 40