A streamlined, more efficient and less burdensome pathway to medical device review is the goal of the Accreditation Scheme for Conformity Assessment (ASCA), a voluntary program the FDA is formally…
Roche’s cobas malaria test is the first molecular test to screen blood donors for the disease to be approved by the FDA. Source: Drug Industry Daily
As negotiators hash out prices for certain top-selling Medicare Part D drugs, the maximum fair price (MFP) could ultimately be far below the actual value that the drug offers to…
Over the past week, the FDA published a proposed rule to ban electrical stimulation devices and issued guidance on bioavailability and bioequivalence testing samples. Draft guidance was issued on animal…
A new draft guidance issued by the FDA Friday provides recommendations for using animal studies to assess the in vivo performance of dental bone grafting materials. Source: Drug Industry Daily
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar…
Americans are being gouged by the “outrageously high price” of a popular diabetes drug, charged Sen. Bernie Sanders (I-Vt.) Wednesday in a scathing rebuke of Novo Nordisk. Source: Drug Industry…
The FDA announced a 23 percent increase in the OTC Monograph Drug User Fee Program (OMUFA) facility fee rates for FY 2024. Source: Drug Industry Daily
The FDA and U.S. Customs and Border Protection (CBP) are partnering to promote supply chain traceability and improve the government’s visibility into imports by focusing on Global Business Identifiers (GBI),…
AstraZeneca has sued to block an Arkansas law that requires the company to ship its drugs to any pharmacy — for-profit or otherwise — working with hospitals participating in the…