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The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met Monday to consider dosing and labeling for Regeneron Pharmaceuticals’ aflibercept as a treatment for retinopathy of prematurity (ROP), a leading cause of childhood blindness. Read More
The vaccine demonstrated noninferiority in antibody response compared to Pfizer’s 20-valent pneumococcal conjugate vaccine Prevnar 20 in 20 serotypes, the company said. Read More
The European Medicines Agency (EMA) is the first regulator to adopt the International Council for Harmonization (ICH) new guideline Q13 on continuous manufacturing (CM) of drug substances and drug products, effective July 10, 2023. Read More
In the wake of the FDA allowing the so-called abortion pill to be dispensed via pharmacies, removing the requirement that the drug only be given to patients in a healthcare setting, the Center for Drug Evaluation and Research (CDER) has rejected two related citizen petitions — one to restrict use and the other to expand the indication. Read More
Novartis has agreed to pay $245 million in settlements to end antitrust cases that claimed the drugmaker delayed the launch of generic versions of its hypertension medicine Exforge (amlodipine and valsartan) in the U.S. market. Read More
Two final documents from the FDA outline a standardized structure and language for risk evaluation and mitigation strategy (REMS) documents to make them more clear and consistent and submissible in Structured Product Labeling (SPL) format. Read More
Medicare Part B patients are having to pay more for their drugs because the Centers for Medicare & Medicaid Services (CMS) process for overseeing data on the average sales price (ASP) of medications is inadequate, the HHS Office of Inspector General (OIG) says in two reports released this week. Read More
The International Council for Harmonization (ICH) has released a first draft of a new guideline that offers parameters for bioequivalence (BE) studies of immediate-release solid oral drugs, including considerations for selecting study participants. Read More
The FDA is facing serious challenges as it seeks to build criminal investigations into illicit FDA-regulated products, says Catherine Hermsen, FDA Assistant Commissioner for Criminal Investigations, who stepped down at the end of the year. Read More
The Department of Justice (DOJ) has filed a civil suit against AmerisourceBergen for the company’s alleged role in the opioid epidemic for violating its “critical responsibility in distributing controlled substances to customers across the country.” Read More