USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – CDER chief: Improving clinical trials is on to-do list
Encouraging researchers and sponsors to simplify clinical trials and employ a fit-for-purpose protocol is one way that the US Food and Drug Administration (FDA)...
France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
VILLEJUIF (Val-de-Marne), BORDEAUX (TICsanté) - Le centre de lutte contre le cancer Gustave-Roussy a noué un partenariat avec l'entreprise bordelaise Synapse Medicine, qui développe...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
USA – Drugmakers, advocacy groups ask FDA to clarify expanded access draft guidance
Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently...
USA – Provider groups, researchers raise concerns about extrapolating adult data in children
Clinicians and researchers are voicing concerns that the US Food and Drug Administration (FDA) has overemphasized the role for extrapolating adult data in pediatric...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
France – La HAS actualise la doctrine vaccinale de lutte contre les orthopoxvirus
Les orthopoxvirus constituent une famille de virus à laquelle appartiennent la variole, mais aussi la vaccine et le mpox (nouveau nom du virus monkeypox). Comme...
International – ICH releases draft guideline proposing harmonized bioequivalence testing
The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release...
France – Avis de sécurité des Hospices civils de Lyon sur le LAP Easily
Les Hospices civils de Lyon (HCL) ont émis le 29 décembre un avis de sécurité sur le logiciel d'aide à la prescription (LAP) Easily...
