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.
A federal court this week entered a consent decree against a Pennsylvania compounder for manufacturing purportedly sterile drugs in insanitary conditions. Read More
The FDA released draft guidance on clinical trial designs for treatments of eosinophilic esophagitis (EoE), a chronic inflammatory disease, including recommendations for selecting trial participants. Read More
The FDA issued a warning to Lymol Medical for failing to submit a final postmarketing requirement (PMR) report on its sterile talc product without providing a good explanation for the delay. Read More
Compounder Pentec Health agreed to pay $17 million to settle a false claims case brought by the U.S. Attorney for the Eastern District of Pennsylvania. Read More
Drugmaker and pharmacist groups called on the FDA to amend its draft guidance on supply chain verification systems, saying the draft doesn’t account for the varying conditions at facilities. Read More
Sponsors may not have to conduct new efficacy trials for the anti-opioid treatment buprenorphine injections or implants if there are existing data for similar products under a final guidance issued Wednesday. Read More
High drug prices cannot solely be laid at the feet of drug manufacturers, said Peter B. Bach, a director at the Memorial Sloan Kettering Cancer Center. Read More