Center for Biologics Evaluation and Research

 

Click the to access content on the FDA's server. Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 10/14/2008 Approval Information: C1 Esterase Inhibitor (Human) (CINRYZE) - Lev Pharmaceuticals, Inc. Posted: 10/10/2008, Approval Date: 10/10/2008 FDA Licenses for Marketing New Therapy for Rare Genetic Disease Posted: 10/10/2008 Supplement Approval: Antihemophilic Factor (Recombinant) Kogenate FS - Bayer HealthCare LLC. Posted: 10/10/2008, Approval Date: 10/10/2008 FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A Posted: 10/10/2008 Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008 FEDERAL REGISTER: Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures, Final Rule Posted: 10/9/2008 Vacancy Announcement - Supervisory Medical Officer, DEB/OBE Posted: 10/9/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 10/8/2008 Vacancy Announcement - Engineers (Mechanical, Electrical and Biomedical Engineer) Posted: 10/8/2008 Vacancy Announcement - Engineers (Mechanical, Electrical and Biomedical Engineer) Posted: 10/8/2008 Medical Device Notification (PSN-08-09) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. Posted: 10/7/2008, Recall Date: 9/30/2008 Exemptions and Alternative Procedures Under 21 CFR Part 1271.155 - Update Posted: 6/13/2006 Vacancy Announcement - Mathematical Statistician, OBE Posted: 10/7/2008 Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Product (PDF - 125 KB) Posted: 10/7/2008; Issued: 9/30/2008 PDUFA Pilot Project Proprietary Name Review; Concept Paper (PDF -295 KB) Posted: 10/7/2008; Issued: 9/30/2008 Vacancy Announcement - Consumer Safety Officer, DRB/DBA/OBRR Posted: 10/7/2008 Untitled Letter: Antithrombin III, Human (Thrombate III), Talecris Biotherapies, Inc. Posted: 10/7/2008 Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Alphabetical List of Registered Establishments Posted: 10/6/2008 Vacancy Announcement - Medical Officer, DVRPA/OVRR Posted: 10/6/2008 Public Workshop: Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States - Transcript Posted: 10/3/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 10/1/2008 Approval Information: Tuberculin, Purified Protein Derivative (Aplisol) - JHP Pharmaceuticals, LLC Posted: 10/1/2008, Approval Date: 9/23/2008 Vacancy Announcement - Health Scientist (HS)/Lead/Supv HS Posted: 9/30/2008 Vacancy Announcement - Health Scientist (HS)/Lead/Supv HS Posted: 9/30/2008 Approval Information: Blood Grouping Reagent Anti-e (Monoclonal) Corrected Approval Letter - Biotest Medical Diagnostics GmbH Posted: 09/26/2008, Approval Date: 9/23/2008 PDUFA - User Fee Billable Products Approved Under Section 351 of the PHS Act - Updated Posted: 9/26/2008 Substantially Equivalent 510(k) Device - HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System - Hemerus Medical, LLC Posted: 9/25/2008, Clearance Date: 9/11/2008 Approval Information: Protein C Concentrate (Human) - Summary Basis for Approval - Baxter Healthcare Corp. Posted 9/25/2008 Information About Heparin and Plasma Derived Products Posted: 9/25/2008 Vacancy Announcement - Supervisory Regulatory Counsel, ADPRP/OCD Posted: 9/25/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 9/24/2008 SOPP 8416: CBER Initiated Second Level STNs Posted: 9/24/2008 SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff Posted: 9/23/2008 Vacancy Announcement - Biologist/Lead/Supv Biologist Posted: 9/19/2008 Vacancy Announcement - Microbiologist /Lead /Supv Microbiologist Posted: 9/19/2008 FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule; Correction Posted: 9/19/2008 Public Workshop: Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry Posted: 9/19/2008 Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Statistical Review and Evaluation Posted:9/18/2008 PDA/FDA Joint Meeting - Slide Presentations Posted: 9/18/2008 Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO Posted: 9/18/2008 Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO Posted: 9/18/2008 International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies Posted: 9/17/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 9/17/2008 Vacancy Announcement - Pharmacologist, OD/DVRPA/OVRR Posted: 9/17/2008 Vacancy Announcement - Supervisory Interdisciplinary Scientist, AEB or VSB/DE/OBE Posted: 9/16/2008 Vacancy Announcement - Supervisory Medical Officer, AEB or VSB/DE/OBE Posted: 9/16/2008 Supplement Approval: Rotavirus Vaccine, Live, Oral, Pentavalent Posted:9/16/2008, Approval Date: 9/5/2008 SOPP 8119: Handling of Regulatory Electronic Communications Posted: 9/16/2008 13th Annual GMP by the Sea: CBER Update - Slide Presentation Posted: 9/16/2008 SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments Posted: 9/15/2008 Substantially Equivalent 510(k) Device - MCS+ 9000 System Posted: 9/15/2008, Clearance Date: 9/15/2008 Substantially Equivalent 510(k) Device - Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System Posted: 9/15/2008, Clearance Date: 9/15/2008 Substantially Equivalent 510(k) Device - PLASMALINK Posted: 9/15/2008, Clearance Date: 9/8/2008 FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers Posted: 9/15/2008 FDA Approves Treatment for Rare Neurologic Disease Posted: 9/15/2008 Approval Information: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Merck Posted: 9/12/2008; Approval Date: 9/12/2008 Approval Information: Immune Globulin Intravenous (Human) (Gamunex) - Talecris Biotherapeutics, Inc. Posted: 9/12/2008; Approval Date: 9/12/2008 Substantially Equivalent 510(k) Device - Pool Results Manager Version 1.0C Posted: 9/12/2008, Clearance Date: 9/3/2008 Important Notification: Red Cell Collection Kits - Haemonetics Corporation Posted: 9/12/2008: Notification Date: 9/9/2008 Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) - Approval History and Related Documents Posted: 9/12/2008 Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone) - Approval History and Related Documents Posted: 9/12/2008 Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Approval history and related documents Posted: 9/12/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 9/10/2008 Vacancy Announcement - Supervisory Medical Officer, DVRPA/OVRR Posted: 9/9/2008 Vacancy Announcement - Supervisory Interdisciplinary Scientist, DVRPA/OVRR Posted: 9/9/2008 Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF) Posted: 9/9/2008 Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation Posted: 9/9/2008, Recall Date: 8/22/2008 FEDERAL REGISTER: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, Final Rule Posted: 9/8/2008 Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases Posted: 9/8/2008 Licensed Products and Establishments List - Update Posted: 9/5/2008, Updated through: 8/31/2008 Cleared Biological 510(k) Device Applications - Update Posted: 9/5/2008, Updated through: 8/31/2008 Approved Biological Premarket Approval (PMA) Device Applications - Update Posted: 9/5/2008, Updated through: 8/31/2008 Approved Biological NDA and ANDA Applications - Update Posted: 9/5/2008, Updated through: 8/31/2008 Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. Posted: 9/5/2008, Recall Date: 8/15/2008 International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals Posted: 9/4/2008 Vaccines and Related Biological Products Advisory Committee Meeting Posted: 9/3/2008, Meeting Date: 9/25/2008 Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update Posted: 9/3/2008 Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action Posted: 9/3/2008 Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action Posted: 9/3/2008 Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action Posted: 9/3/2008 Public Workshop: Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products - Agenda Posted: 9/2/2008   View Earlier News     Back to Top   Other News Digests… FDA - CDER | Today's Health & Pharma News | Drug Thesaurus | DMFs | Search | Site Map   © 2008 Betterchem.com