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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 FDA has extended its review of Phathom Pharmaceuticals’ new drug application (NDA) for vonoprazan, an acid-blocking drug used to treat erosive esophagitis, a severe form of acid reflux that damages the lining of the esophagus. 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
Intercept Pharmaceuticals has resubmitted its new drug application (NDA) for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis secondary to nonalcoholic steatohepatitis (NASH). Read More
The FDA hit Smithfield Bioscience with a Form 483 over unexplained batch discrepancies for its blood thinner heparin — a repeat observation from 2019 — following a July 2022 inspection of the company’s Cincinnati, Ohio, facility. Read More
During fiscal 2022, a period where the FDA ramped up its onsite drug inspections after a pandemic-era decline, the agency significantly targeted pharma companies for sterility-related concerns. 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