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- Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book. Updated.
- CDER Organization Charts - CDER Organization Charts (updated)
- Celgene issues a Dear Healthcare Professional letter for Innohep - Celgene issues a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency
- DDMAC Letter - Division of Drug Marketing, Advertising, and Communications Letter: HUMIRA (adalimumab) Injection, Abbott
- DDMAC Letter - Division of Drug Marketing, Advertising, and Communications Letter: Xodol ( hydrocodone bitartrate and acetaminophen) tablets
- Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations - Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations
- Drug Approval Reports - Drug Approval Reports
- Drug Firm Annual Registration Status - Drug Firm Annual Registration Status updated. The status report now includes Data Universal Numbering System Number.
- Drug Shortages: Current Drug Shortages; Cisplatin Injection 1mg/ml - APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64). Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks. Bedford has all presentations, including Novaplus presentations, on backorder with no release date.
- Drugs@FDA Downloadable Data Files (updated) - Drugs@FDA Downloadable Data Files (updated)
- Drugs@FDA Downloadable Data Files (updated) - Drugs@FDA Downloadable Data Files (updated)
- Drugs@FDA Downloadable Data Files (updated) - Drugs@FDA Downloadable Data Files (updated)
- ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets - ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets
- FDA approves degarelix for injection for patients with advanced prostate cancer - FDA approves degarelix for injection for patients with advanced prostate cancer
- FDA report - FDA releases a study that finds much of private-sector consumer medication information is not consistently useful
- FDA warns consumers about tainted weight loss pills - FDA warns consumers about tainted weight loss pills
- Guidance for Industry - Bioequivalence Recommendations
- Guidance for Industry - Comprehensive List of Guidance Documents
- Guidance for Industry - Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
- Guidance for Industry - Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
- Guidance for Industry - New/Revised/Withdrawn List for 2008
- Guidance for Industry - Orally Disintegrating Tablets
- List of Authorized Generic Drugs - Office of Generic Drugs: List of Authorized Generic Drugs (updated)
- MedWatch item on antiepileptic drugs - FDA is requiring that all manufacturers of antiepileptic drugs include a Warning in their labeling and develop a Medication Guide to be provided to patients to inform them of the risks of suicidal thoughts or actions.
- 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)
- November First-Time Generic Drug Approvals - Office of Generic Drugs: Month First-Time Generic Drug Approvals
- Office of Generic Drugs: Determination of Dorzolamide-Timolol Maleate Ophthalmic Solution Exclusivitiy - Office of Generic Drugs: Determination of Dorzolamide-Timolol Maleate Ophthalmic Solution Exclusivitiy
- Paragraph IV Patent Certifications - Office of Generic Drugs: Paragraph IV Patent Certifications (updated)
- Paragraph IV Patent Certifications - Office of Generic Drugs: Paragraph IV Patent Certifications (updated)
- Rulemaking History for Nonprescription Products - Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
