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.
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying such nonclinical studies should consider general toxicology, pharmacology and reproductive toxicology. Read More
FDA Commissioner Scott Gottlieb said the agency will continue to take action against compounders who produce drugs under substandard conditions. Read More
Generics spending dropped $5.5 billion in the United States in 2017 due largely to competition and price decreases, according to the IQVIA Institute for Human Data Science report, Medicine Use and Spending in the U.S. A Review of 2017 and an Outlook to 2022. Read More
In a reversal, the National Institutes of Health said the Helping to End Addiction Long-term Initiative (HEAL) — the trans-agency effort to combat the opioid crisis launched early this month — will decline cash contributions from drug companies. Read More
FDA Commissioner Scott Gottlieb said pharmacy benefit managers may be “complacent participants” in schemes to stifle biosimilar competition and raise drug prices by keeping cheaper versions of drugs off the market. Read More
Clinical trials for depot buprenorphine products for opioid dependence treatment should not focus on standard endpoints, but also consider novel efficacy endpoints not directly focused on opioid use, according to new guidance released by the FDA. Read More
The federal government issued a notice of proposed rulemaking that would postpone its revisions to the Common Rule on the use of human subjects in clinical trials for another six months and opened up discussion on the permitting of three burden-reducing provisions in the 2018 requirements for regulated entities. Read More