Federal Register notice: FDA posts a list of recent information collections that have been approved by OMB.
Federal Register notice: FDA seeks public comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA...
FDA publishes a report with charts of bioresearch monitoring inspections from FY 2017.
FDA issues Evolus a complete response letter on its BLA for potential Botox competitor DWP-450 (prabotulinumtoxinA) for treating glabellar lines.
FDA accepts for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial lung dise...
The federal government intervenes in five whistleblower suits against Insys Therapeutics over improper payments to healthcare professionals to induce ...
FDA clears a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals a...
FDA researchers highlight the varying participation rates of women in various types of cardiovascular clinical trials.