Update : 1
Subject: FDA Data Standards Update - SPL Release Four Evaluation Material for Registration & Listing
Greetings,
The zip file containing the SPL Release Four evaluation material for registration and listing was updated Saturday, March 15, 2008, to include an additional document: SPL for Registration and Listing v0.2.
SPL Release Four Evaluation Material for Registration and Listing - http://www.fda.gov/oc/datacouncil/SPL_r4_registration_and_listing_material_v0.3.zip
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 2
Subject: CDER's Small Business Assistance Workshop
Registration is open now. To register, call Saira Roberts at 214-860-5887. Space is limited to 150 participants. We appreciate advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. For more information, call Saira Roberts at 214-860-5887 or David Arvelo at 214-253-4952 or david.arvelo@fda.hhs.gov.
http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
Update : 3
Subject: CDER New 3/17/2008
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March 17, 2008
- New and Generic Drug Approvals
- ACZONE (dapsone) Gel, QLT Inc., Efficacy Supp. w/Clinical Data
- Amifostine Injection, Sun Pharma, Approval
- Azmacort (triamcinolone acetonide) Inhalation Aerosol, Abbott Labs, Labeling Revision
- Bupropion Hydrochloride Extended-Release Tablets, Actavis, Approval
- FLOLAN (epoprostenol sodium) Injection, GlaxoSmithKline, Labeling Revision
- Granisetron Hydrochloride Injection, Wockhardt, Tentative Approval
- Hydroxyzine Hydrochloride Tablets, InvaGen Pharma, Approval
- MERREM I.V. (meropenem) Injection, AstraZeneca, Labeling Revision
- Moban (molindone hydrochloride) Tablets, Endo Pharma, Labeling Revision
- NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Patient Population Altered
- Paroxetine Hydrochloride Tablets, Mylan Pharma, Approval
- SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Manufacturing Change or Addition
- Tramadol Hydrochloride Tablets, Pliva Inc., Control Supplement
- Tramadol Hydrochloride Tablets, Pliva Inc., Facility Addition
- Tramadol Hydrochloride Tablets, Pliva Inc., Manufacturing Revision
- Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop.
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