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TXT FDA Alert Admitted as Evidence in Malpractice Case [309 Words] [ Price : $8.95]
Attorney Steve McConnell criticizes a Tennessee federal court decision to admit into evidence in a medical malpractice case an FDA alert on fentanyl patches based on adverse event reports.
10/29/2014
 
 
TXT CDRH Supporting Devices for the Disabled: Maisel [353 Words] [ Price : $8.95]
CDRH chief scientist William Maisel says the Center is working with medical device manufacturers to further development of innovative devices to aid the disabled.
10/29/2014
 
 
TXT FDA OKs First Vaccine for Serogroup B Meningococcal Disease [194 Words] [ Price : $8.95]
FDA approves Wyeth Pharmaceuticals’ Trumenba, the first vaccine in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
10/29/2014
 
 
TXT FDA Sends Collection of Info on Biologic AERs to OMB [55 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on adverse experience reporting for licensed biological products to the Office of Management and Budget.
10/29/2014
 
 
TXT Collection of Info on Smokeless Tobacco Sent to OMB [37 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the pH of smokeless tobacco products to the Office of Management and Budget.
10/29/2014
 
 
TXT Comments Sought on FDA-IND Sponsor Communication [74 Words] [ Price : $8.95]
Federal Register Notice: FDA establishes a docket to receive recommendations on best practices for communication between FDA and IND sponsors during drug development.
10/29/2014
 
 
TXT Suggestions Made for Informed Consent Guidance [470 Words] [ Price : $8.95]
Stakeholders say an FDA draft guidance on the informed consent information sheet may lead to a document that is too complex for many trial participants to understand.
10/29/2014
 
 
TXT Bill to Speed Ebola Treatments Coming [236 Words] [ Price : $8.95]
Sens. Harkin and Alexander say they will introduce legislation to add Ebola to the list of qualifying tropical diseases for an FDA voucher program that could speed development of treatments for the disease.
10/29/2014
 
 
TXT Ex-FDAer John Taylor Joins Regulatory Consulting Firm [206 Words] [ Price : $8.95]
Former FDA counselor to the commissioner John Taylor joins Greenleaf Health as compliance and regulatory affairs principal.
10/29/2014
 
 
TXT FDA Refutes Takeda Safety Challenge Over Colcrys Competitor [397 Words] [ Price : $8.95]
FDA says it did not err when it approved Hikma Pharmaceuticals’ 505(b)(2) application last month for Mitigare (colchicine) capsules.
10/29/2014
 
 
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