2026 FDA Packaging 
The FDA Law Blog
FEBRUARY 2, 2025
The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. The most common drug Californians may be looking for this winter is Paxlovid.
pharmaphorum
AUGUST 6, 2020
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.
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The FDA Law Blog
FEBRUARY 21, 2024
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3
pharmaphorum
OCTOBER 1, 2020
Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. Jakafi had sales of more than $1.1
Pharmaceutical Technology
JUNE 19, 2025
By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026. The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations.
European Pharmaceutical Review
SEPTEMBER 26, 2023
This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. The site is planned to be completed by 2026.
DiversifyRx
JULY 11, 2024
Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The exemption will last until November 27, 2026, for those small dispensers who qualify. We need more clarity here to see what the FDA is planning.
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