Federal Register notice: FDA makes available a draft guidance entitled Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Developmen...
Federal Register notice: FDA announces a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to identify wh...
FDA grants de novo marketing for Natural Cycles Nordics Natural Cycles mobile medical application that can be used as a method of contraception to pre...
Hologics Cynosure division suspends marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, ...
A federal court in Pennsylvania denies a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab.
FDA clears a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery system for cranial surgery.
FDA proposes a new Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads that is intended to research wheth...
FDA accepts for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in patients who require con...