Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Source: Drug Industry…
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list…
This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s…
Several Philips BiPAP devices and certain Baxter Life2000 ventilator systems are under FDA Class I recalls, the most serious type of recall, as use of the devices can result in…
Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday.…
Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them…
This month Takeda struggles to find the bright side of disappointing phase 3 data, Pfizer touts “unprecedented” lung cancer success, NS Pharma’s Duchenne muscular dystrophy drug fails in phase 3,…
Merck and Daiichi Sankyo’s non-small cell lung cancer drug suffered a setback with the companies’ receipt of an FDA complete response letter (CRL) identifying third party manufacturer inspection issues as…
The ongoing effort by the FTC to remove what it labels improper and inaccurate — or “junk” — listings of drug patents in the FDA’s Orange Book continues, with all…
In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the…