custopharm
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Cancer-Drug Shortages Targeted by Stopgap FDA Approval of Similar Products
5:08 AM Feb 22nd
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FDA Says Part 11 Guidance Remians Status Quo via @
6:39 AM Feb 21st
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FDA sets draft rules for biotech drug copies | Fox News via @
11:46 AM Feb 10th
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House introduces bipartisan legislation creating user fees for generic drugs.
5:49 AM Feb 10th
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Judge Rules For FDA In Generic Enoxaparin Approval Case.
5:43 AM Feb 8th
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Beta testing for Aspire eCTD is underway. If interested let me know.
6:31 AM Jan 29th
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JANUARY 23, 2012
Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?
5:43 AM Jan 26th
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FDA Recommends Three Drug User Fee Programs
5:29 AM Jan 24th
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Apple, America and a Squeezed Middle Class: an interesting perspective as to why jobs move overseas.
9:11 AM Jan 23rd
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FDA Notifies Health Care Providers about the Risks of Purchasing Unapproved
Injectable Cancer Medications
4:57 AM Jan 17th
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FDA would collect millions in fees to speed review of traditional and biotech generic drugs - The Washington Post
4:56 AM Jan 17th
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FDA Hits Seven-Year High On Medicine Approvals
4:32 AM Jan 6th
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WEBINAR: CDER-CBER Town Meeting: FDA Discusses the US Module 1 Update - Drug Information Association:
6:12 AM Jan 4th
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University: New medication shortages hit 267 drugs in 2011, for 5th straight yearly increase
5:55 AM Jan 4th
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Joint Audit by UK and French Regulatory Agencies with the FDA highlight aseptic filling process deficiencies
9:14 AM Dec 12th, 2011
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New Article FDA & EMA to share manufacturing GMP site inspections
7:12 AM Dec 12th, 2011
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FDA requires DMFs submitted in eCTD format to comply with PDF specifications for hyperlinks, bookmarks and TOCs.
10:57 AM Dec 7th, 2011
via web
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GDUFA Performance Goals and Procedures posted on FDA web site; calls for eCTD format to meet review metrics
10:46 AM Dec 7th, 2011
via web
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Health insurer charging unreasonable rate increases: Everence Insurance of Pennsylvania is charging small busine...
5:49 AM Nov 27th, 2011
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FDA Warns Mylan About Violations At Puerto Rico Plant
5:37 AM Nov 23rd, 2011
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- Name Custopharm Inc.
- Location Carlsbad, CA
- Web http://www.custop...
- Bio CUSTOpharm is a pioneering company focused on eCTD submissions to the FDA. We have been submitting exclusively in the eCTD format since 2004.
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