Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging 111

Packaging Labelling Documentation Dosage 111

FDA Law Blog: Biosimilars

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] report certain device malfunctions, and.

Labelling 62

Labelling Communication Documentation 62

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. It should be noted that 21 CFR 803.18(b)(1)(ii)

Labelling 62

Labelling Communication 62

Pharmaceutical Technology

MAY 25, 2023

The ongoing Phase 1/2a ( NCT04725331 ) study is a multicentre, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with the anti-PD-1 treatment, Keytruda. Analysis estimates that the oncolytic virus market will reach $1 billion by 2026. Keytruda for the trial is provided by MSD (Merck & Co).

Labelling 52

Labelling Communication Vaccines 52