USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
USA – Pharma industry making some headway in DSCSA implementation
The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA),...
USA – Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient...
Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in...
France – Essais cliniques de médicaments : toutes les demandes de transition doivent être...
Le REC est entré en vigueur le 31 janvier 2022. Il a remplacé la directive 2001/20/CE (transposée en France dans la loi Jardé).
Depuis cette...
USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
International – Industry groups call for changes in ICH M11 guideline on harmonized protocols
In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11...
USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients...
USA – FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
