President Biden continued to push for extending the prescription drug cost-cutting provisions of the Inflation Reduction Act (IRA) beyond Medicare recipients in a speech broadcast on YouTube on Wednesday. Source:…
Two pharmaceutical giants — AstraZeneca and Eli Lilly — endured 483 knocks recently: AZ for releasing an out-of-spec bilayer tablet and Lilly for lapses in aseptic technique. Source: Drug Industry…
This edition of Quick Notes reviews the FDA’s clearance of Abbott’s hand-held rapid blood test for traumatic brain injury, Eko’s AI-powered stethoscope that can detect low ejection fraction (EF), Beacon’s…
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have…
This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary…
Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical…
A corporate culture that values quality management at every level is key to achieving and maintaining high-quality data throughout the life cycle of all in vivo bioavailability (BA) and bioequivalence…
New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied…
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and…
Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports. Source: Drug Industry Daily