USA – FDA Approves First Nonprescription Daily Oral Contraceptive
Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for...
USA – Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
Industry stakeholders urged the US Food and Drug Administration (FDA) to postpone its October 2023 deadline for testing drug products for novel nitrosamines, saying...
USA – Postmarketing requirements: FDA drafts guidance on determining non-compliance
The US Food and Drug Administration (FDA) has released a draft guidance for sponsors on how the agency determines an applicant has demonstrated good...
Europe – EMA statement on ongoing review of GLP-1 receptor agonists
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including...
USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy...
A US Food and Drug Administration (FDA) official discussed the agency’s recent efforts to spur the development of cell and gene therapies during a...
France – Stratégie de vaccination contre la Covid-19 : actualisation des recommandations relatives à...
Les données d’immunogénicité qui montrent à la fois une réponse humorale Covid-19 similaire et une réponse humorale plus faible en cas de coadministration des...
USA – Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused...
The last draft guidance on using clinical outcomes assessments (COA) as endpoints in patient-focused drug development (PFDD) should use terminology more consistently, align more...
UK – Novavax COVID-19 vaccine produces immunity
Researchers leading the University of Oxford’s Com-COV3 study have delivered results from a study researching the immune response and side-effect profile of ‘mixed’ two-dose...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises),...
