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TXT FDA Sends Info on Biosimilar Products to OMB [55 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on formal sponsor-FDA meetings on biosimilar biologic products.
06/05/2015
 
 
TXT FDA Issues 2 EUAs for Ebola Assays [164 Words] [ Price : $8.95]
Federal Register Notice: FDA issues two Emergency Use Authorizations for in vitro diagnostic devices for detecting the Ebola virus as requested by Corgeniz, Inc. and Cepheid.
06/05/2015
 
 
TXT Guidance on Qualified Importers for Human/Animal Food [128 Words] [ Price : $8.95]
Federal Register Notice: FDA is making available a draft guidance for industry on the Voluntary Qualified Importer Program for importers of human or animal food.
06/05/2015
 
 
TXT Janssen Begins BLA for Multiple Myeloma [183 Words] [ Price : $8.95]
Janssen Research & Development begins a rolling BLA submission to FDA for Daratumumab for certain patients with multiple myeloma.
06/05/2015
 
 
TXT Panel Backs Female Sexual Dysfunction Drug with Risk Plan [439 Words] [ Price : $8.95]
An FDA advisory committee votes to support approval of a Sprout Pharmaceuticals NDA for flibanserin and its use for women seeking to improve their sexual desire, as long as a risk management plan to limit safety risks is in place.
06/04/2015
 
 
TXT Duodenoscope Probe Widens: Reports [239 Words] [ Price : $8.95]
News accounts say that the Justice Department is now looking at two additional medical scope manufacturers in connection with its probe of “superbug” infections related to duodenoscopes.
06/04/2015
 
 
TXT FDA Clears Roche Cobas Test for Herpes Virus [101 Words] [ Price : $8.95]
FDA clears a Roche 510(k) for its cobas HSV 1 and 2 Test for detecting and differentiating [Herpes Simplex Virus] HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients.
06/04/2015
 
 
TXT FDA Withdraws NADA for Keet Life Bird Seed [48 Words] [ Price : $8.95]
Federal Register Notice: FDA withdraws approval of a Hartz Mountain NADA for Keet Life Bird Seed at the sponsor’s request.
06/04/2015
 
 
TXT 21st Century Cures Could Be Step Backward: Researchers [589 Words] [ Price : $8.95]
Harvard researchers Jerry Avorn and Aaron Kesselheim outline several provisions in the 21st Century Cures Act that they fear could take drug and medical device approvals backwards.
06/04/2015
 
 
TXT Validate Scope Reprocessing Processes: Comment [374 Words] [ Price : $8.95]
Stakeholders comment on a Gastroenterology and Urology Devices Panel meeting dealing with cleaning and reprocessing of duodenoscopes.
06/04/2015
 
 
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