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.
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
With user fee legislation now firmly in place, a new Congress ready to begin legislating in 2023, and an omnibus package signed into law funding the FDA for another year, we talked with Steven Grossman, executive director of the Alliance for a Stronger FDA, about the big issues that face the agency as we head into the new year. Read More
The FDA has granted Ardelyx’s appeal following a Complete Response Letter, allowing the company to resubmit a new drug application (NDA) for its chronic kidney disease (CKD) drug candidate Xphozah (tenapanor). Read More
An inadequate response to a Form 483 about deviations in current good manufacturing practice (cGMP) led to an FDA warning letter for MD Pharmaceutical Supply’s active pharmaceutical ingredients (API) repackaging and relabeling facility in Hanover, Pa. Read More
Trading on an inside-track relationship with FDA regulators, Biogen leveraged the Accelerated Approval pathway to bring to market its controversial antiamyloid antibody, Aduhelm (aducanumab), an 18-month Congressional investigation has found. Read More
Ipsen Biopharmaceuticals has received a Complete Response Letter (CRL) from the FDA for palovarotene, the company’s investigational treatment for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP). Read More