Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Act Questions and Answ...
FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirements and FDA certificat...
Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metastatic urothelial cance...
California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (adalimumab), indicated ...
After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH lifts their hopes for...
Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approval Changes to Drug Su...
FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product identifiers.
Attorney Anne Walsh says the Justice Department has directed its civil litigators to oppose court attempts to impose nationwide injections, including ...