We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Comments filed on the FDA’s proposed guidance on potency assurance for cellular and gene therapy (CGT) products reflect the intricacies that set these treatments apart from drug interventions. Read More
Six manufacturers of numbing gels, creams and sprays marketed to relieve pain from cosmetic procedures have received FDA Warning Letters for concentrations of lidocaine in their products in excess of the allowance of 4 percent for OTC topical pain relief products. Read More
The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard. Read More
The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found. Read More
Closing on May 31, the European Medicines Agency (EMA) has opened a second consultation for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials. Read More