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TXT Draft Guide on Drug Study Expansion Cohorts [80 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.”
08/13/2018
 
 
TXT Workshop on Patient Perspectives Used for Clinical Trials [135 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to identify what is most important to patients and caregivers with respect to disease burdens, treatment burdens, and the benefits and risks in managing a patient’s disease.
08/13/2018
 
 
TXT Mobile App Cleared as Contraceptive Method [227 Words] [ Price : $8.95]
FDA grants de novo marketing for Natural Cycles Nordic’s Natural Cycles mobile medical application that can be used as a method of contraception to prevent pregnancy.
08/13/2018
 
 
TXT Hologic’s Cynosure Unit Suspends Marketing of Vaginal Device [142 Words] [ Price : $8.95]
Hologic’s Cynosure division suspends marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, due to FDA concerns about such devices.
08/13/2018
 
 
TXT Court Denies J&J Motion Against Pfizer’s Biosimilar [172 Words] [ Price : $8.95]
A federal court in Pennsylvania denies a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab.
08/13/2018
 
 
TXT 7D Surgical Cranial Surgery Module Cleared [113 Words] [ Price : $8.95]
FDA clears a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery system for cranial surgery.
08/13/2018
 
 
TXT FDA to Study ‘Overwarning’ in DTC Ads [170 Words] [ Price : $8.95]
FDA proposes a new “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads” that is intended to research whether regulatory requirements can cause counterproductive “overwarning.”
08/13/2018
 
 
TXT FDA Accepts UCB NDA for Seizure Nasal Spray [113 Words] [ Price : $8.95]
FDA accepts for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive seizures).
08/13/2018
 
 
TXT Product Approval Summaries [1425 Words] [ Price : $8.95]
FDA Review posts product approval summaries for the week ending 8/10/2018.
08/12/2018
 
 
TXT Draft Guide on Modernizing Clinical Trial Designs [321 Words] [ Price : $8.95]
FDA releases a new draft guidance that is intended to modernize clinical trial designs in oncology drug development.
08/10/2018
 
 
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