Archive for March 2024

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 implementing while targeting accreditation bodies, testing labs and device manufacturers. Source: Drug Industry Daily

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 patients, according to researchers at the Tufts Center for the Study of Drug Development (CSDD). Source: Drug Industry Daily

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 Draft guidance was issued on animal studies for dental bone grafting. Facility fee rates for FY 2024 for the OTC Monograph Drug User Fee program were published. Source: Drug Industry Daily

A new draft guidance issued by the FDA Friday provides recommendations for using animal studies to assess the in vivo performance of dental bone grafting materials.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 device. Source: Drug Industry Daily

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 Daily

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), unique numbers that capture information about legal business entities and their functions within the supply chain. Source: Drug Industry Daily

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 controversial 340B federal discount program. Source: Drug Industry Daily