Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority A List.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40