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TXT FDA Selects 7 Disease Areas for Patient-Focused Initiative [89 Words] [ Price : $8.95]
Federal Register Notice: FDA announces seven disease areas to be addressed during fiscal years 2016-2017 for its Patient-Focused Drug Development Initiative.
07/06/2015
 
 
TXT Guidance on Product Tracing for Dispensers [112 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy.
07/06/2015
 
 
TXT CDER Seeks Electronic Health Record Demonstrations [85 Words] [ Price : $8.95]
Federal Register Notice: CDER seeks demonstration projects on an end-to end electronic health record to electronic data capture approach.
06/26/2015
 
 
TXT Comments Sought on E-User Fee [43 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on electronic user fee payment request forms.
06/26/2015
 
 
TXT Info on Emergency Shortages Sent to OMB [46 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on emergency shortages data collection to the Office of Management and Budget.
06/26/2015
 
 
TXT Judge Sentences Device Company Ex-CEO to 2 Years in Jail [243 Words] [ Price : $8.95]
A New Jersey federal judge sentences OtisMed Corp.’s former chief executive officer, Charlie Chi, to 24 months in prison, and ordered him to pay a $75,000 fine.
06/26/2015
 
 
TXT 3rd Circuit Appeals Court Broadens ‘Pay for Delay” Consideration [223 Words] [ Price : $8.95]
The Third Circuit Court of Appeals rules that large cash settlements by innovator drug companies to would-be generic competitors are not the only basis for determining anticompetitive behavior under the U.S. Supreme Court’s FTC v. Actavis ruling.
06/26/2015
 
 
TXT CBER Letter Cites ‘Unapproved’ Cell Products at BioDlogics [161 Words] [ Price : $8.95]
A CBER-directed inspection at BioDlogics finds that the company’s amniotic-membrane based products require approved BLAs in order to be distributed.
06/26/2015
 
 
TXT Wharton Paper Finds FDA Device System ‘Optimal’ [309 Words] [ Price : $8.95]
A new paper from the University of Pennsylvania’s Wharton School finds that FDA’s regulatory framework for approving and clearing devices is “pretty close to optimal,” whereas the European Union’s system is too lax.
06/26/2015
 
 
TXT Guidance on Unique Device ID [98 Words] [ Price : $8.95]
Federal Register Notice: FDA is making available a draft guidance entitled Unique Device Identification: Direct Marking of Devices.
06/26/2015
 
 
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