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Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)...
Doxycycline: currently available evidence not supporting link with risk of suicidality
EMA’s safety committee (PRAC) has concluded that the currently available evidence is not sufficient...
USA – Final FDA guidance on PCCP includes clarification on version...
The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices...
International – Mpox : les efforts commencent à « porter leurs...
Cent jours après la déclaration d’urgence de santé publique de portée internationale (Usppi) concernant le virus monkeypox, « nous commençons à voir des signes positifs montrant...
China – China Issues Guidelines on Children’s Cosmetics
On August 31, 2023, the National Institute of Food and Drug Control (“NIFDC”) issued a notice on the “Technical Guidelines for Children’s Cosmetics” (the...
