BioPortfolio Limited Cancer: An Almost Ideal Clinical Application of Molecular Imaging -Lung Cancer -Breast Cancer --Advanced Research Technologies’ SoftScan -Ovarian Cancer --CIS Bio’s INDIMACIS 125 -SPECT Receptor Imaging Agents for Neuroendocrine Tumors --Mallinckrodt Medical’s OctreoScan --Diatide’s NeoSpect / Neotect (Technetium-99m depreotide) --Draximage’s Iodine-123...
Therapeutic Biological Approvals FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Therapeutic Biological Approvals - Tradename/ Proper Name Indication for Use STN Manufacturer/ License No
CBER - 1996 Biological License Application Approvals FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page 1996 Biological License Application Approvals This list reflects information regarding the applications as of the approval date
author: CBER / FDA
Pharmaceutical Research and Manufacturers of America - Immunomedics Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes AFP-Scan* AFP-Scan* / technetium-99m-FAb' fragment Immunomedics Morris Plains, NJ Phase II location and extent of disease staging of...
Pharmaceutical Research and Manufacturers of America - Breast Cancer Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes 715992 (kinesin inhibitor) none / none Breast Cancer Ovarian Cancer GlaxoSmithKline Research Triangle Park, NC Phase I - Advexin none / none...
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER Prescription Drug User Fee Act User Fee Billable Therapeutic Products Approved Under Section 351 of the PHS Act This list is intended to include all the user fee billable therapeutic biological products and potencies approved under Section 351 of the Public Health Service Act that have been transferred...
CBER Transfer of Therapeutic Products to CDER Alteplase Activase Genentech, Inc Anakinra Kineret Amgen, Inc Anistreplase Eminase Wulfing Pharma GmbH Arcitumomab CEA -Scan Immunomedics, Inc Asparaginase Elspar Merck & Co., Inc Basiliximab Simulect Novartis Pharmaceuticals Corp Becaplermin Regranex OMJ Pharmaceuticals, Inc Becaplermin Concentrate - Chiron Corp Botulinum Toxin Type A BOTOX BOTOX COSMETIC Allergan,...
author: FDA / CBER
http://www.bioportfolio.com/cgi-bin/acatalog/rbhc0083t.pdf page 6
Medicinal Products with a Community Marketing authorisation - Status October 2002 page 4 List Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: List
http://www.phrma.org/publications/publications//2002-10-21.601.pdf M ore than 250 million people have already benefited from medicines and vaccines developed through biotechnology, and a new survey offers hope that many more will benefit in the future
duplicates:http://www.phrma.org/newmedicines/resources/2002-10-21.93.pdf
http://www.phrma.org/publications/publications//2002-10-21.601.pdf page 35
duplicates:http://www.phrma.org/newmedicines/resources/2002-10-21.93.pdf
http://www.phrma.org/publications/publications//2002-10-21.601.pdf page 8
duplicates:http://www.phrma.org/newmedicines/resources/2002-10-21.93.pdf
Medicinal Products with a Community Marketing authorisation, Status-September 2002 page 4 Table Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: Table
duplicates:http://www.emea.eu.int/pdfs/general/direct/listprod/1640502en.pdf
http://www.phrma.org/newmedicines/resources/bio00.pdf San Francisco, CA immunotherapy low- grade non- Hodgkin's lymphoma I 131 tositumomab SmithKline Beecham Philadelphia, PA BrevaRex AltaRex MAb breast cancer, multiple myeloma, Phase I antibody- based Waltham, MA MUC1- expressing tumors immunotherapy CA4P OXiGENE angiogenesis advanced cancer, solid tumors Phase I/ II Boston, MA inhibitor Campath ® Millennium Pharmaceuticals MAb...
http://www.phrma.org/newmedicines/resources/bio00.pdf page 32
http://www.phrma.org/newmedicines/resources/bio00.pdf page 8
http://www.phrma.org/newmedicines/resources/bio00.pdf page 7
December 17, 2001 page 15
author: BioCentury Publications Inc.
subject: BioCentury
http://www.emea.eu.int/pdfs/human/press/pr/087196en.pdf The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html London, 16 October 1996 CPMP/ ...
author: Jerry Wells
http://www.emea.eu.int/pdfs/human/press/pr/087196en.pdf page 4 The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html ANNEX II to CPMP- Oct 96 Press ...
author: Jerry Wells
http://www.emea.eu.int/pdfs/human/press/pr/087196en.pdf page 1 The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html London, 16 October 1996 CPMP/ ...
author: Jerry Wells
CPMP 18-20 September 2001 Plenary meeting - Technical meeting report page 6 Technical meeting report CPMP/ 2358/ 01 6/ 13 ANNEX 3 to CPMP September 2001 OUTCOME OF THE SEPTEMBER 2001 CPMP MEETING IN RELATION TO CENTRALISED APPLICATIONS IN THE POST- AUTHORISATION PHASE Opinions for Type I Variation applications following Type II procedure Number of Opinions Outcome 2 Positive by consensus Opinions ...
author: CPMP
subject: Technical meeting report
chrmscat.p65 page 1
author: cxm9300
CBER Biological Product Deviation Reporting - Non-Blood Product Codes Poverty GU61 - Marshelder, True (Rough) GU62 - Mexican Tea GU63 - Mormon Tea GU64 - Mugwort GU65 - Mugwort, California GU66 - Mugwort, Common GU67 - Mugwort, Darkleaved GU68 - Mustard, Black GU69 - Mustard, Common Yellow GU70 - Mustard, White< br> GU71 - Nettle GU72 - Nettleleaved Goosefoot GU73 - Palmer's Amaranth GU74 - Pickleweed GU75 - Pigweed GU76 - Pigweed, Green GU77 - Pigweed...
author: CBER / FDA
Non-Blood Product Codes: Biol Product Deviation Reporting Poverty GU61 Marshelder, True (Rough) GU62 Mexican Tea GU63 Mormon Tea GU64 Mugwort GU65 Mugwort, California GU66 Mugwort, Common GU67 Mugwort, Darkleaved GU68 Mustard, Black GU69 Mustard, Common Yellow GU70 Mustard, White GU71 Nettle GU72 Nettleleaved Goosefoot GU73 Palmer's Amaranth GU74 Pickleweed GU75 Pigweed GU76 Pigweed, Green GU77 Pigweed, Rough Redroot GU78 Pigweed, Spiny...
author: CBER FDA
