Dockets

Overall Benefit to Risk Considerations for COX-2 Selective Nonsteroidal Anti-Inflammatory Drugs and Related Agents (New 5/5/05)

ANDA for a Generic Version of Efudex Cream(fluorouracil) Cream (Updated 8/9/06)

Nonclinical and Clinical Datasets; Notice of Pilot Project (New 3/22/05)

Draft Guidance for Industry on and as: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information

Laser Light Show (New 12/16/04)

Agency Information Collection Activities; Proposed Collection; Medwatch: the FDA Medical Projects Reporting Program; Comment Request (New 3/22/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling (New 3/8/05)

Medical Devices; Medical Device Reporting (New 6/2/05)

Generic Fluticasone Propionate Nasal Spray Products Meet the Same High Standards of Quality as GSK's Brand-name Product Lonase (Updated 8/13/07)

Off Label Drug Use for CYTOTEC (Updated 6/20/06)

180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (New 6/1/05)

Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing (New 8/24/07)

Stay approval of any ANDAs submitted by Ivax Pharmaceuticals, Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat (doxycycline hyclate 20 mg) is the reference listed drug unless that ANDA's bioequivalence study or studies include female subjects (5/31/05)

Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey (New 6/7/05)

To Amend Regulation Update Estrogens Increase the Risk of Endometrial Cancer Prescribing Info of All Strengths of Premarin Tablets (New 5/20/05)

ANDA for Methacholine Chloride 1280 mg/vial (New 5/22/06)

Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association (New 2/28/05)

2004D-0484: Guidance for Industry on the Role of HIV Drug Resistance Testing in Anteiretroviral Drug Development (New 3/11/05)

Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDS) (New 3/3/05)

Vitamin D and Calcium and Reduced Risk of Osteoporosis (New 10/27/05)

Food Labeling: Prominence of Calories (New 8/23/05)

Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(B)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization (New 2/28/05)

Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis and Impact on Dosing and Labeling (New 3/22/05)

Reclassification of the Buechel-Pappas Unconstrained Ankle Prosthesis (Updated 9/05/07)

Food Labeling: Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes (New 6/10/05)

Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting (New 12/9/04)

ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets (New 6/9/06)

Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG7119.05)" (Updated 5/31/05)

DERMA-SMOOTHE/FS(fluocinolone acetonide 0.01% topical oil) (Updated 9/7/07)

2004D-0443

Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations (Updated 3/3/05)

Guidance for Industry on Computerized Systems used in Clinical Trials (Updated 3/3/05)

Regulatory Site Visit Training Program (New 12/9/04)

Reject New Drug Application 21-695

Food Labeling: Safe Handling Statements: Labeling of Shell Eggs (New 6/7/05)

International Conference on Harmonisation; Draft Guidance on S7B Nonclincial Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTC Interval Prolongation and Proarrhythmic Potential for N0n-Antiarrhythemic Drugs

Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use (New 3/22/05)

Amend Food Additive Regulations in 172.380 Vitamin D3 to Permit the Use of Vitamin D3 in Cheese and Cheese Products at a Level Above That Permitted Under 184.1950 Vitamin D (New 10/05/04)

Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial (New 05/22/2006)

Request for Advisory Opinion (21 CFR 808.5) or Exemption (21 CFR 808.1,808.10); Regarding Automatic External Defibrillators (New 8/24/07)

Scientific Considerations Related to Developing Follow-on Protein Products (Updated 6/2/06)

Citizen Petition Requesting Certain Actions with Respect to Vaccines and Other Drug Products, Containing Added Mercury, in Order to Reduce the Health Risk to Susceptible Fetuses, Newborns, Children, Adolescents and Adults (Updated 6/11/07)

ANDA For Fluticasone Propionate Nasal Spray, 50 MCG (New 5/27/05)

Hospital Bed System Dimensional Guidance to Reduce Entrapment (Updated 6/8/06)

Refuse to file Abbreviated New Drug Application (ANDA) for the Combination Drug Amlodipine Besylate-benazepril Hydrochloride (amlodipine-benazepril) (New 8/4/06)

2004N-0337

Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; a Functional Magnetic Resonance Study (Updated 9/20/05)

Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients (Updated 9/15/04)

Request Public Hearings Regarding the Sales, Distribution and Use of Hand-held Doppler Fetoscopes (New 6/15/06)

Civil Money Penalty Re: Ecumed Health Group, Inc. (New 3/3/05)

Refrain from Approving Certain Applications Submitted Under Section 505(B)(2) of the FDCA that Rerference Depakote (Divalproex Sodium Delayed-Release Tablets) (Updated 8/10/06)

Nutrient Content Claims for Carbohydrates (New 2/25/05)

Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (New 10/05/04)

Laser Light Show (New 1/25/05)

Initiate Proceedings to Permit Computerized Thermal Iimaging, Inc. (CTI) to Supplement the Administrative Record in Connection with CTIS Premarket Approval Application in P010035 (New 1/25/05)

Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Human Use, can Contain in Combination Both Sulfur (10.0%) and Salicylic Acid (2.0%) as the Active Ingredients (New 1/25/05)

Notice Announcing Publication of the Report to Congress Entitled "Plan for the Transfer of Responsibility for Medicare Appeals" and Soliciting Comments (New 8/09/04)

Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed with, or Otherwise Containing Material from Cattle (New 10/04/04)

Stimulating Innovation in Medical Technologies(Updated 12/22/04)

2004P-0231: Deny Approval of NDA 21-426 for Ominitrop 5.8 mg Somatropin [rDNA origin] for Injection, Lyophilized Powder and Diluent with Preservative (New 05/31/2006)

Whole Grain Descriptive Claims (Updated 5/1/06)

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(F) B (Updated 9/15/04)

Nutrient Content Claims: DHA, PEA, and ALA (Omega-3-Fatty Acids) (New 12/9/04)

Public Information Regulations (New 10/25/04)

Pandemic Influenza Preparedness and Response Plan (New 11/10/04)

Guidance: Clinical Trial Design for Hip Replacement Systems (New 5/10/04)

Furan in Food; Thermal Treatment (New 6/23/05)

Qualified Health Claim (QHC); Lycopene, Tomatoes and Cancer (Updated 12/28/05)

Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (New 7/20/05)

Guidance for Industry on Development and Use of Risk Minimization Action Plans (New 7/20/05)

Guidance for Industry on Premarketing Risk Assessment (New 7/20/05)

Nutrient Content Claim: Expand the Definition of Lean (New 4/27/04)

Critical Path Initiative (Updated 11/16/04)

Intervet Inc. is Requesting Permission to File an ANADA for a Generic Intravaginal Progesterone Insert for Cattle that Differs from the Pioneer Product (EAZI-BREED TM CIDR; NADA 141-200 in Strength (New 8/24/07)

Standards for 'Similarity' or 'Sameness' of Biotechnology-derived Products (Updated 7/12/06)

Exemption from the Medical Devices Tracking Requirements for Heartstream automated External Defibrillators (New 12/02/04)

Valley Forge Composite Technologies Explosive Detection Systems (New 12/16/04)

ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg. (New 6/2/05)

Qualified Health Claim (QHC): Chromium Picolinate and Diabetes (Updated 12/1/04)

Petitioner Requests the Commissioner to Determine that NDA 19-44, Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for Safety or Effectiveness Reasons (New 8/24/07)

Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling (Updated 7/16/04)

Part II, Electronic Record; Electronic Signatures; Public Meeting (Updated 9/13/04)

Prescription Drug Importation; Public Meeting (Updated 7/13/04)

Nutrient Content Claim: Carbohydrate Content in Food (Grocery Manufactures of America) (New 3/12/04)

Nutrient Content Claim: Carbohydrate Content in Food (ConAgra Foods) (New 3/1/04)

Nutrient Content Claim: Carbohydrate Content in Food (Kraft Foods North America Inc) (Updated 5/4/05)

Qualified Health Claim (QHC): Calcium and Kidney/Urinary Stones (Updated 10/19/04)

Qualified Health Claim (QHC): Calcium and Bone Fractures (Updated 1/31/05)

Qualified Health Claim (QHC): Calcium and Menstrual Disorders (Updated 9/15/05)

Qualified Health Claim (QHC): Calcium and Hypertension (Updated 11/15/05)

Qualified Health Claim (QHC): Calcium and Various Cancers (Updated 10/21/04)

Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cancer (Updated 6/21/05)

BSE Risk Materials in Foods and Cosmetics (New 11/8/04)

Oxandrolone and Widely used Anti-coagulant Durgs Containing the Active Drug Warfarin (Updated 5/3/06)

Qualified Health Claim (QHC) for Eggs with Enhanced Omega-3 Fatty Acid Content and a Balanced 1:1 Ratio of Omega-3/Omega-6 Fatty Acids and Reduced Risk of Heart Disease and Sudden Fatal Heart Attack (Updated 5/4/04)

Health Claim Petition: Glucosamine Sulfate and Osteoarthritis (Updated 9/7/05)

Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis (Updated 11/24/04)

Issue a Written Opinion Stating that Bio-Rad's Longstanding Practice, Previously Accepted by the Agency, of Developing Unified, Truthful Labeling for Domestic and International Sales of its Control Products is Lawful (New 5/23/07)

Requests that the Commissioner of Food and Drug Admination Determine that Astra Zenecal LP's Dyclone(dyclonine hydrochloride) Topical Solution 0.5% and 1.0%(NDA 9-925) was Voluntarily withdrawn or withheld from sale for Reasons Other than Safety or Efficacy (New 8/24/07)

Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application (New 1/7/05)

Deny Approval of any New Drug Application (NDA) for Recombinant Salmon Calcitonin (RESCT) Nasal Spray (Updated 10/12/05)