DrugBank

FEBRUARY 9, 2023

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. DrugBank Powered Research: Pharmacological knowledge about drug targets was analyzed based on a query of DrugBank. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

Clinical Pharmacology 52

Clinical Pharmacology Molecular Biology DNA Licensing 52

Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA 40

FDA Science Regulations Production 40