The FDA provides clarity for drugmakers in a final guidance on how the agency’s considerations about a drug’s risks and benefits factor into NDA and BLA premarket and postmarket decisions.…
Though it might seem counterintuitive given the complex regulations and procedures required of the drug and device development industries, the real key to better quality lies in simplifying operations, said…
Illumina has already begun preparing for the divestment of Grail, although the company has already filed a challenge against the order with the European Court of Justice, claiming that the…
The FDA handed out a fistful of approvals this week, including three for Merck’s juggernaut PD-1 blocker Keytruda, bringing the drug’s total indications to 36. Source: Drug Industry Daily
Novo Nordisk will pay KBP Biosciences up to $1.3 billion to acquire ocedurenone, a drug for uncontrolled hypertension with potential applications in cardiovascular and kidney disease, the companies announced on…
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process…
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine…
CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered…
The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs. Source: Drug Industry Daily
The FDA’s final guidance alerts drugmakers and compounders to the potential health hazard of alcohol (ethyl or ethanol) or isopropyl alcohol that is contaminated with methanol. Source: Drug Industry Daily