February 16, 2009Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Alprostadil 0.5 mg/mL injection See Related Information section Source: www.fda.gov January First-Time Generic Drug Approvals Office of Generic Drugs: January First-Time Generic Drug Approvals Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7: Dissolution Test General Chapter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Adverse Event Reporting System (AERS) Statistics(updated) Adverse Event Reporting System (AERS) Statistics (updated) Source: www.fda.gov Forum Conference - Cytokine Therapies: Novel Approaches for Clinical Indications, March 26 and 27, 2009, NYAS Conference Center, New York City, NY: This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Meeting Information. Source: www.nyas.org Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov # posted by Network @ 6:13 PM
 |
Subscribe to Posts [Atom]