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The FDA is providing a public list of all approved ANDAs for drugs that received a Competitive Generic Therapy (CGT) designation and will note which ANDAs are for drugs that were also eligible for CGT exclusivity. Read More
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). Read More
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 Draft guidance was issued on animal studies for dental bone grafting.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. Read More
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. Read More
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. Read More
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. Read More
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. Read More