On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more
The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more
In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more