Search
Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
26 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...
News
05 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which...
News
06 July 2023
The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional...
News
07 June 2023
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the...
News
06 June 2023
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the...
News
28 March 2023
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will...
News
19 January 2023
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should...
News
08 November 2022
Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal...
News
08 March 2022
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding...
