Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
USA – FDA finalizes guidance on DSCSA verification systems
The US Food and Drug Administration (FDA) on 7 December issued a final guidance describing procedures to help trading partners establish systems to identify,...
UK – AstraZeneca/Merck’s Lynparza combination recommended by NICE for advanced ovarian cancer
The drug has been specifically recommended for NHS use alongside Genentech’s Avastin (bevacizumab) as a maintenance treatment in adults with advanced epithelial ovarian, fallopian...
USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
EMA’s safety committee, PRAC, has recommended new measures for medicines containing...
France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à...
L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a observé une « augmentation constante du nombre de déclarations de réactions allergiques graves...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can...
