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TXT Generally Positive Comments on PDUFA 7 Letter [2930 Words] [ Price : $8.95]
Six stakeholders submit their comments on FDA’s PDUFA 7 commitment letter.
10/28/2021
 
 
TXT Cardinal Health Contract on Real World Evidence [321 Words] [ Price : $8.95]
FDA awards Cardinal Health a $750,000 contract to implement an 18-month real world evidence study to help the agency advance RWE in regulatory decision-making.
10/28/2021
 
 
TXT Covid Brought FDA Focus on Real-World Data: Report [2763 Words] [ Price : $8.95]
A Bloomberg Law report says FDA is likely to place greater emphasis on real-world data in future regulatory decisions.
10/27/2021
 
 
TXT FDA OK’s Labeling Change on Heart Failure Device [251 Words] [ Price : $8.95]
FDA approves a labeling modification on Impulse Dynamics’ Optimizer Smart medical device, allowing the removal of a “normal sinus rhythm” limitation from the indications for use statement.
10/27/2021
 
 
TXT Machine Learning Principles for Device Development [2710 Words] [ Price : $8.95]
FDA joins with Canadian and UK regulators to promote 10 guiding principles for good machine learning practice for medical devices.
10/27/2021
 
 
TXT Regulatory Review Period Determined for Xenleta [91 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Nabriva Therapeutics’ Xenleta injection (lefamulin).
10/27/2021
 
 
TXT Regulatory Review Period Determined for Inrebic [97 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Impact Biomedicines’ Inrebic (fedratinib), indicated for the treating myelofibrosis.
10/27/2021
 
 
TXT ICH Looking to the Future [2709 Words] [ Price : $8.95]
The International Council on Harmonizations looks at changes it must make to evolve with the process of drug development in a changing healthcare system.
10/27/2021
 
 
TXT ElZarrad Named CDER OMP Director [2623 Words] [ Price : $8.95]
CDER appoints M. Khair ElZarrad as director of the Office of Medical Policy.
10/27/2021
 
 
TXT Advisors on Makena Must be ‘Fairly Balanced’: Public Citizen [2795 Words] [ Price : $8.95]
Public Citizen calls on FDA to ensure that the membership of an advisory committee considering whether Covis’ Makena should be withdrawn is fair and balanced.
10/27/2021
 
 
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