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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FDA releases a new draft guidance that is intended to modernize clinical trial designs in oncology drug development.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
 
 
TXT Workshop on Human Skin Safety Testing for Topicals [100 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.”
08/10/2018
 
 
TXT FDA Approves Alnylam’s Onpattro for Nerve Disease [406 Words] [ Price : $8.95]
FDA approves an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis in adult patients.
08/10/2018
 
 
TXT FDA Proposes New Drug Promotion Study on Disclosures [115 Words] [ Price : $8.95]
Federal Register notice: FDA submits to OMB a new information collection study entitled “Disclosures in Professional and Consumer Prescription Drug Promotion” (OMB Control Number 0910-New).
08/10/2018
 
 
TXT Long-term Contraceptive Ring Approved [113 Words] [ Price : $8.95]
FDA approves a Population Council NDA for Annovera, first vaginal ring contraceptive that can be used for an entire year.
08/10/2018
 
 
TXT Spacelabs Healthcare Recalls Anesthesia Device [102 Words] [ Price : $8.95]
Spacelabs Healthcare recalls the Arkon Anesthesia Delivery System due to the device going into a “failed state,” which causes the mechanical ventilation function to stop working.
08/10/2018
 
 
TXT Vyaire Medical Recalls AirLife Resuscitation Device [114 Words] [ Price : $8.95]
Vyaire Medical recalls its AirLife Resuscitation Device due to a manufacturing error.
08/10/2018
 
 
TXT FDAers Find Increases in Tropical Disease Drug Development [272 Words] [ Price : $8.95]
Writing in PLOS online journal, three FDA researchers find a significant increase in the development of new tropical disease drugs after Congress enacted the priority review voucher legislation.
08/10/2018
 
 
TXT Drug Complex Innovative Designs Pilot Program [160 Words] [ Price : $8.95]
FDA outlines its planned “Complex Innovative Designs Pilot Meeting Program” that is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs.
08/09/2018
 
 
TXT Guide on Drug Dissolution Testing [78 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.”
08/09/2018
 
 
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