HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS

Welcome to FDAweb Pay Per View Search our 70,821 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Next >>   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     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     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     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     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     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     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     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     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     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     << Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25  Next >>

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com