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Tag: fda
Ethicon EVARREST Fibrin Sealant Patch Now FDA Approved for Liver Surgery
2015-04-06 22:34:24| Food - Topix.net
Ethicon , a part of J&J , received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation.
Tags: approved
surgery
patch
liver
FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements
2015-04-03 07:01:53| Biotech - Topix.net
Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.
Tags: requirements
citizen
applicant
petition
Swedish Match gears up for closely watched FDA panel meeting
2015-04-02 20:17:25| Appliances - Topix.net
In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm-based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes. The closely watched vote could pave the way for the first Food and Drug Administration approval of a modified risk tobacco product and set a precedent for companies seeking to make similar claims.
Tags: match
meeting
panel
closely
PCI Medical Announces 510(k) Submission to FDA for Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Probes
2015-04-02 12:31:11| Industrial Newsroom - All News for Today
PCI Medical announces that it has submitted the GUS ASTRA VR and GUS ASTRA TEE to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, and that the submission is now in substantive review. The GUS ASTRA VR is an automated reprocessor for the high-level disinfection of endovaginal/endorectal...
Tags: medical
submission
tee
automated
FDA Warning Letter Sent to Moy-Fincher Medical Group
2015-04-02 07:00:00| Happi Breaking News
DNA Eye Renewal claims in question.
Tags: group
medical
letter
warning
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