| Monday | Tuesday | Wednesday | Thursday | Friday |
| 7/27 | 7/28 | 7/29 | 7/30 | 7/31 |
| 7/20 | 7/21 | N/A | 7/23 | 7/24 |
| N/A | 7/14 | 7/15 | 7/16 | 7/17 |
| 7/6 | 7/7 | 7/8 | N/A | 7/10 |
| 7/1 | 7/2 |
| 7/31/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 073198co.pdf | 073198co.txt | ||||
| NADA 46-592 | New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate | CVM | Final Rule | 40824 | 073198a.pdf | 073198a.txt |
| 98N-0171 | Medical devices: Humanitarian use devices Withdrawn | CDRH | Final Rule | 40825 | 073198b.pdf | 073198b.txt |
| 98N-0144 | Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License | CBER | Proposed Rule | 40858 | 073198c.pdf | 073198c.txt |
| Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 40912 | 073198d.pdf | 073198d.txt | |
| 98F-0584 | DuPont Chemicals and White Pigments and The Dow Chemical Co.; Filing of Food Additive Petition (FAP 8B4607) | CFSAN | Notice | 40912 | 073198e.pdf | 073198e.txt |
| 7/30/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 073098co.pdf | 073098co.txt | ||||
| 76N-052n | Cold, cough, allergy, bronchodilator, and antiasthmatic products for over-the counter human use; Amendment ofmonograph for OTC Nasal Decongestant Drug Products | CDER | Final Rule | 40647 | 073098a.pdf | 073098a.txt |
| 98n-0513 | Medical devices: Neurological Devices; Classification of Cranial Orthosis | CDRH | Final Rule | 40650 | 073098b.pdf | 073098b.txt |
| 98n-0467 | Medical devices: Effective date of Requirement for Premarket Approval for Three Class III preamendments physicalmedicine devices | CDRH | Proposed rule | 40677 | 073098c.pdf | 073098c.txt |
| 98n-0405 | Medical Devices; Retention in Class III and Effective Date of Requirement for Premarket Approval for Three preamendmentsClass III Devices | CDRH | Proposed rule | 40673 | 073098d.pdf | 073098d.txt |
| 98n-0572 | Agency information collection activities: Proposed collection; comment request | OC | Notice | 40716 | 073098e.pdf | 073098e.txt |
| 98N-0194 | Agency information collection activities; Submission for OMB review; comment request | OC | Notice | 40718 | 073098f.pdf | 073098f.txt |
| 98D-0264 98D-0265 98D-0266 98D-0267 98D-0293 98D-046898D-0372 98D-027298D-0466 98n-0339 | FDA Modernization Act of 1997; implementation: Public dockets establishment | CDER CBER CDRH CVM | Notice | 40719 | 073098g.pdf | 073098g.txt |
| 98F-0593 | Dover Chemical Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 40720 | 073098h.pdf | 073098h.txt |
| 83F-0089 | Food additive petitions: National Starch & Chemical Corp.; withdrawn | CFSAN | Notice | 40720 | 073098i.pdf | 073098i.txt |
| 98D-0449 | Draft Compliance Program Guidance Manual: Inspection Of Medical device manufacturers | CDRH | Notice | 40720 | 073098j.pdf | 073098j.txt |
| Draft Compliance Program Guidance Manual: Inspection Of Medical device manufacturers | 980449gd.pdf | |||||
| 98D-0566 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal ProductsNew animal drugs; stability testing (three guidances) | CVM | Notice | 40721 | 073098k.pdf | 073098k.txt |
| Draft Guidance on Stability Testing of New Animal Drug Substances and Products (#73) | CVM | 98566gd1.pdf | ||||
| Stability Testing for New Dosage Forms of New Animal Drugs (#74) | CVM | 98566gd2.pdf | ||||
| Stability Testing: Photostability Testing of New Animal Drug Substances and Products (#75) | CVM | 98566gd3.pdf | ||||
| 7/29/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF Name | TXT Name |
| Table of Contents | 072998co.pdf | 072898co.txt | ||||
| 96P-0228 | Medical Devices; Reclassification and Codification of Vitamin D Test System | CDRH | Final Rule | 40364 | 072898a.pdf | 072898a.txt |
| Relating Numbers of Foodborne Pathogens to Human Illness; Public Workshop | CFSAN | Notice | 40531 | 072898b.pdf | 072898b.txt | |
| Food Safety Risk Assessment Clearinghouse; Open Meeting and Technical Workshop | CFSAN | Notice | 40530 | 072898c.pdf | 072898c.txt | |
| 98D-0548 | Draft Guidances for Industry on the Development of Antimicrobial Drug Products;Availability | CDER | Notice | 40532 | 072898d.pdf | 072898d.txt |
| Uncomplicated urinary tract infections | CDER | guidance | 2567dft.pdf | |||
| Uncomplicated and complicated skin and skin structure infections | CDER | guidance | 2566dft.pdf | |||
| Community-acquired pneumonia | CDER | guidance | 2570dft.pdf | |||
| Nosocomial pneumonia | CDER | guidance | 2571dft.pdf | |||
| Acute bacterial exacerbation of chronic bronchitis | CDER | guidance | 2568dft.pdf | |||
| Secondary bacterial infection of acute bronchitis | CDER | guidance | 2564dft.pdf | |||
| Acute otitis media | CDER | guidance | 2617dft.pdf | |||
| Acute uncomplicated gonorrhea | CDER | guidance | 2561dft.pdf | |||
| Acute sinusitus | CDER | guidance | 2565dft.pdf | |||
| Complicated urinary tract infections and pyelonephritis | CDER | guidance | 2559dft.pdf | |||
| Bacterial prostatitis | CDER | guidance | 2563dft.pdf | |||
| Early Lyme disease | CDER | guidance | 2574dft.pdf | |||
| Empiric therapy of febrile neutropenia | CDER | guidance | 2560dft.pdf | |||
| Vulvovaginal candidiasis | CDER | guidance | 2558dft.pdf | |||
| Streptococcal pharyngitis and tonsillitis | CDER | guidance | 2562dft.pdf | |||
| Bacterial meningitis | CDER | guidance | 2573dft.pdf | |||
| Bacterial vaginosis | CDER | guidance | 2572dft.pdf | |||
| 98D-0448 | Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables; Availability | CDRH | Notice | 40533 | 072898e.pdf | 072898e.txt |
| Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables | CDRH | guidance | 980448gd.pdf | |||
| 7/28/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT File |
| Table of Contents | 072898co.pdf | 072898co.txt | ||||
| 98F-0567 | The Dow Chemical Co.; Filing of Food Additive Petition [FAP 8B4601] | CFSAN | Notice | 40297 | 072898a.pdf | 072898a.txt |
| 7/27/98 | ||||||
|---|---|---|---|---|---|---|
| Docket | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table Of Contents | 072798co.pdf | 072798co.txt | ||||
| 98N-0274 | Food Labeling; Petitions for Nutrient Content and Health Claims, General Provisions; Correction | CFSAN | Final rule; correction | 40024 | 072798a.pdf | 072798a.txt |
| 95N–0176 | Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems | CDRH | Final rule. | 40025 | 072798b.pdf | 072798b.txt |
| 97N-0511 93N-0325 97N-0296 | Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice; Extension of Comment Period; Correction | CFSAN | Proposed rule; preliminary regulatory impact analysis; extension of comment period;correction. | 40072 | 072798co.pdf | 072798c.txt |
| 98N-0518 | Public Information; Communications With State and Foreign Government Officials | OC | Proposed rule | 40069 | 072798d.pdf | 072798d.txt |
| 98F-0571 | BASF Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 40125 | 072798e.pdf | 072798e.txt |
| 98F-0568 | FMC Corp.; Filing of Food Additive Petition | CFSAN | Notice | 40126 | 072798f.pdf | 072798f.txt |
| Granulocytes for Transfusion: Research and ClinicalExperience; Public Workshop | CBER | Notice | 40126 | 072798g.pdf | 072798g.txt | |
| Evaluation of In Vivo Efficacy of Platelet Transfusion Products and Platelet Substitutes; Public Workshop | CBER | Notice | 40126 | 072798h.pdf | 072798h.txt | |
| 97N-0497 | Hematopoietic Stem/Progenitor Cell Products: Discussion of Unrelated Allogeneic Placental/Umbilical Cord Blood and Peripheral Blood Cell Banking and Transplantation; Notice of Public Workshop | CBER | Notice of Public Workshop | 40127 | 072798i.pdf | 072798i.txt |
| 98D-0049 | Guidance for Industry on Environmental Assessment of Human Drug and Biologics Applications; Availability | CBER | Notice | 40127 | 072798j.pdf | 072798j.txt |
| Guidance for Industry on Environmental Assessment of Human Drug and Biologics Applications | CBER | Draft Guidance | 980049gd.pdf | |||
| 98D-0563 | CDRH Draft Guidance For Industry: Contents of a Product Development Protocol; Availability | CDRH | Notice | 40128 | 072798k.pdf | 072798k.txt |
| CDRH Draft Guidance For Industry: Contents of a Product Development Protocol | CDRH | Draft Guidance | 980563gd.pdf | |||
| 98D-0545 | Draft Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods; Availability | CBER | Notice | 40129 | 072798l.pdf | 072798l.txt |
| Draft Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods | CBER | Draft Guidance | 980545gd.pdf | |||
| 7/24/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 072498co.pdf | 072498co.txt | ||||
| ANADA 200-246 | Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension | CVM | Final rule | 39727 | 072498a.pdf | 072498a.txt |
| 97N-0222 | Medical Devices; Preemption of State Product Liability Claims | CDRH | Withdrawal of proposed rule | 39789 | 072498b.pdf | 072498b.txt |
| 98N-0339 | Public Meetings on Section 406(b) of the FDA Modernization Act of 1997 | OC | Notice of meetings | 39877 | 072498c.pdf | 072498c.txt |
| Dental Products Panel of the Medical DeviceAdvisory Committee; Notice of Meeting | OC | Notice | 39879 | 072498d.pdf | 072498d.txt | |
| 98D-0514 | Draft Guidance for Industry on ANDA’s: Impurities in Drug Substances; Availability | CDER | Notice | 39880 | 072498e.pdf | 072498e.txt |
| Draft Guidance for Industry on ANDA’s: Impurities in Drug Substances | CDER | Draft Guidance | 980514gd.PDF | |||
| 7/23/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 072398co.pdf | 072398co.txt | ||||
| 98N-0147 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 39581 | 072398a.pdf | 072398a.txt |
| 98F-0570 | BASF Corp.; Filing of Food Additive Petition | CFSAN | Notice | 39582 | 072398b.pdf | 072398b.txt |
| 98F-0569 | Ticona; Filing of Food Additive Petition | CFSAN | Notice | 39583 | 072398c.pdf | 072398c.txt |
| 7/21/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 072198co.pdf | 072198co.txt | ||||
| NADA 141-088 | New Animal Drugs for Use inl Animal Feeds; Bacitracin Methylene Disalicylate and Nitarsone | CVM | Final rule | 39028 | 072198a.pdf | 072198a.txt |
| 97N-0515 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 39092 | 072198b.pdf | 072198b.txt |
| 98N-0546 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 39093 | 072198c.pdf | 072198c.txt |
| 98N-0517 | Development of Antimicrobial Drug Products; Development and Use of FDA Guidance Documents; Request for Comments | CDER | Notice; Request for comments. | 39096 | 072198d.pdf | 072198d.txt |
| 97E-0358 | Determination of Regulatory Review Periodfor Purposes of Patent Extension; Flowmax | OC | Notice | 39097 | 072198e.pdf | 072198e.txt |
| 98N-0473 98P-0275 98P-0215 98P-0216 98P-0338 | Medical Devices; Exemptions From Premarket Notification; Class II Devices | CDRH | Notice | 39098 | 072198f.pdf | 072198f.txt |
| 98N-0437 | New ModeI Medical Device Development Process; Availability | CDRH | Notice | 39099 | 072198g.pdf | 072198g.txt |
| New ModeI Medical Device Development Process | CDRH | guidance | 980437gd.txt | |||
| 98D-0133 | Revised Guidance for Industry on Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements | CBER | Notice | 39100 | 072198h.pdf | 072198h.txt |
| Revised Guidance for Industry on Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements | CBER | guidance | 980133gd.pdf | |||
| 7/20/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT ID |
| Table of Contents | 072098co.pdf | 072098co.txt | ||||
| NADA 141-085 | New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Zoalene | CVM | Final Rule | 38750 | 072098a.pdf | 072098a.txt |
| NADA 101-479 | Implantation or Injectable Dosage Form New Animal Drugs; Fluxin Meglumine | CVM | Final Rule | 38749 | 07208b.pdf | 072098b.txt |
| 97F-0405 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | CFSAN | Final Rule | 38747 | 072098c.pdf | 072098c.txt |
| 94F-0040 | Secondary Direct Food Additives Permitted in Food for Human Consumption | CFSAN | Final Rule | 38746 | 072098d.pdf | 072098d.txt |
| 76N-052T | Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monography for OTC Antitussive Drug Products | CDER | Notice of Proposed Rulemaking | 38762 | 072098e.pdf | 072098e.txt |
| Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice of Meeting | 38838 | 072098f.pdf | 072098f.txt | |
| 7/17/98 | |||||
|---|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | PDF ID | TXT ID |
| Table of Contents | 071798co.pdf | 071798co.txt | |||
| NADA 65-470 | Oral Dosage Form New Animal Drugs; Bacitracin Methylene Disalicylate Soluble | Final Rule | 38474 | 071798a.pdf | 071798a.txt |
| FREEDOM OF INFORMATION SUMMARY | 65470.pdf | ||||
| ANADA 200-202 | Oral Dosage Form New Animal Drugs; Ivermectin Liquid | Final Rule | 38473 | 071798b.pdf | 071798b.txt |
| FREEDOM OF INFORMATION SUMMARY | 200202.pdf | ||||
| 97D-0291 | Determination of Regulatory Review period for Purposes of Patent Extension; QUADRAMET | Notice | 38656 | 071798c.pdf | 071798c.txt |
| Nonprescription Drugs Advisory Committee: Amendment of Notice | Notice | 38657 | 071798d.pdf | 071798d.txt | |
| Nucleic Acid Testing for Hepatits C Virus (HCV) and Other Viruses in Blood Donors; Public Workshop | Notice | 38658 | 071798e.pdf | 071798e.txt | |
| Oncologic Drugs Advisory Committee; Notice of Meeting | Notice | 38658 | 071798f.pdf | 071798f.txt | |
| 98D-0393 | National Shellfish Sanitation program Guide for the Control of Molluscan Shellfish; Availability | Notice | 38659 | 071798g.pdf | 071798g.txt |
| 7/16/98 | |||||
|---|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | PDF ID | TXT ID |
| Table of Contents | 071698co.pdf | 071698co.txt | |||
| NADA 140-989 | Implantation or Injectable Dosage form New Animal Drugs; Formalin Solution | Final Rule | 38304 | 071698a.pdf | 071698a.txt |
| Freedom of Information Summary | 140989co.pdf | ||||
| Implantation or Injectable Dosage form New Animal Drugs; Spectinomycin Solution; Correction | Notice of correction | 30303 | 071698b.pdf | 071698b.txt | |
| 98N-0494 | Agency Information Collection Activities: Proposed Collection; Comment Request | Notice | 38409 | 071698c.pdf | 071698c.txt |
| 97E-0271 | Determination of Regulatory Review Period for Purposes of Patent Extension; PANDEL Cream | Notice | 38410 | 071698d.pdf | 071698e.txt |
| 98D-0508 | Medical Devices: Draft Global Harmonization Task Force Study Group 3 Process Validation Guidance; Draft; Availability | Notice | 38411 | 071698e.pdf | 071698e.txt |
| 98D-0469 | Draft Guidance for Industry on Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis); Availability | Notice | 38412 | 071698f.pdf | 071698f.txt |
| Draft Guidance for Industry on Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) | Guidance | 980469gl.pdf | |||
| 7/15/98 | |||||
| Docket Number | Document Name | Action | FRN Page | FDF ID | TXT ID |
| Table of Contents | 071598co.pdf | 071598co.txt | |||
| 98N-0394 | Medical Devices; Investigational Device Exemptions | Proposed rule. | 38131 | 071598a.pdf | 071598a.txt |
| Memorandum of Understanding Between the Food and Drug Administration and the Indian Health Service | Notice. | 38182 | 071598b.pdf | 071598b.txt | |
| 7/14/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 071498co.pdf | |||
| Relocation of the Dockets Management Branch;Correction | Notice | 37890 | 071498a.pdf | |
| 98D-0481 | Guidance for Industry on 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendmentsto the Federal Food, Drug, and Cosmetic Act;Availability | Notice | 37890 | 071498b.pdf |
| Guidance for Industry on 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendmentsto the Federal Food, Drug, and Cosmetic Act; | Guidance | 980481gd.pdf | ||
| 7/10/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 071098co.pdf | |||
| 90F-0142 | Indirect Food Additives: Adhesives and Components of Coatings | Final rule | 37246 | 071098a.pdf |
| 98N-0482 | Agency Information Collection Activities: Proposed Collection; Comment Request | Notice | 37394 | 071098b.pdf |
| 98N-0510 | Agency Information Collection Activities: Submission for OMB Review; Comment Request | Notice | 37396 | 071098c.pdf |
| 96E-0452 | Determination of Regulatory Review Period for Purposesof Patent Extension; VERLUMA | Notice | 37397 | 071098d.pdf |
| 97E-0359 | Determination of Regulatory Review Period for Purposes of Patent Extension; Flowmax | Notice | 37399 | 071098e.pdf |
| 97-0061 | Determination of Regulatory Review Period for Purposesof Patent Extension; STROMECTOL | Notice | 37398 | 071098f.pdf |
| Antimicrobial Drugs and Resistance; Notice of Public Meeting | Notice | 37400 | 071098g.pdf | |
| 1998 FDA Science Forum—Biotechnology: Advances, Applications, and Regulatory Challenges | Notice of meeting. | 37400 | 071098g.pdf | |
| 98N-0495 | Prescription Drug User Fee Act, “PDUFA II Five-Year Plan;” Availability | Notice | 37401 | 071098h.pdf |
| Prescription Drug User Fee Act, “PDUFA II Five-Year Plan;” | Plan | 98N0495p.pdf | ||
| 98D-0512 | Draft "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and EstablishmentDescription Information for Human Blood and BloodComponents Intended for Transfusion or for FurtherManufacture and For the Completion of the FDA For | Notice | 37401 | 071098h.pdf |
| Draft "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and EstablishmentDescription Information for Human Blood and BloodComponents Intended for Transfusion or for FurtherManufacture and For the Completion of the FDA For | Draft Guidance | 980512gd.pdf | ||
| 98D-0483 | Draft "Guidance for industry: in the Manufacture and Ciinicai Evacuation of in Vitro Tests to DetectNucieic Acid Sequences of Human immunodeficiencyVirus Type 1;" Avaliability | Notice | 37402 | 071098i.pdf |
| Draft "Guidance for industry: in the Manufacture and Ciinicai Evacuation of in Vitro Tests to DetectNucieic Acid Sequences of Human immunodeficiencyVirus Type 1;" | Draft Guidance | 980483gd.pdf | ||
| 7/8/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 070898co.pdf | |||
| 97N-0524 | Food Labeling: Warning and Notice Statement; Labeling of Juice Products | Final Rule | 37030 | 070898a.pdf |
| 97N-0511 93N-0325 97N--0296 | Hazard Analysis and Critical Control Point (HACCP); andProcedures for the Safe and Sanitary Processing and Importing of Juice; Extension of Comment Period | Proposed Rule; Preliminary regulatory impact analysis; extension of comment period | 37057 | 070898b.pdf |
| Advisory Committees; Filing of Annual Report | Notice | 36920 | 070898c.pdf | |
| 98N-0363 | Agency Information Collection Activities: Proposed Collection; Comment Request | Notice | 36921 | 070898d.pdf |
| 9.80E-308 | Determination of Regulatory Review Period for Purposes of Patent Extension; IVOMEC EPRINEX™ Pour-On for Beef and Dairy Cattle | Notice | 36922 | 070898e.pdf |
| 78N-0070 | Combination Drugs Containing Theophylline, Ephedrine Sulfate, and Hydroxyzine Hydrochloride; Withdrawal ofApproval | Notice | 36923 | 070898f.pdf |
| Anti-Infective Drugs Advisory Committee; Notice ofMeeting; Correction | Notice; correction | 36924 | 070898g.pdf | |
| 7/7/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 070798co.pdf | |||
| 98F-0492 | ICI PLC; Filing of Food Additive Petition | Notice | 36699 | 070798a.pdf |
| Team Biologics; Workshop for Manufacturers of Licensed In Vitro Diagnostics | Notice | 36699 | 070798a.pdf | |
| Memorandum of Understanding Between the Food and Drug Administration and the Defense Alliance for Advanced Medical Terminology | Notice | 36700 | 070798b.pdf | |
| 98D-0265 | Guidance for Industry on Qualifying for Pediatric Exclusivity; Availability; Request for Submissions | Notice | 36707 | 070798c.pdf |
| Guidance for Industry on Qualifying for Pediatric Exclusivity | Guidance | 980265gd.pdf | ||
| 7/6/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 070698co.pdf | |||
| 90F-0220 | Food Additives Permitted for Direct Addition to Foods for Human Consumption; Acesulfame Potassium | Final rule. | 36344 | 070698a.pdf |
| 93F-0286 | Food Additives Permitted for Direct Addition to Foods for Human Consumption; Acesulfame Potassium | Final rule; response to objection, confirmation of effective date. | 36362 | 070698b.pdf |
| 98N-0046 | Quarterly List of Guidance Documents at the Food and Drug Administration | Notice | 36413 | 070698c.pdf |
| 7/2/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 070298co.pdf | |||
| NADA 46-666/668. | New Animal Drugs For Use In Animal Feeds; Penicillin | Final rule | 36179 | 070298a.pdf |
| NADAs 91–818/94-170 | Animal Drugs, Feeds, and Related Products; Change of Sponsor | Final rule | 36178 | 070298b.pdf |
| 97F-0469 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final rule | 36177 | 070298c.pdf |
| 97F-0468 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final rule | 36176 | 070298d.pdf |
| 90F-0435 | Indirect Food Additives: Polymers | Final rule | 36175 | 070298e.pdf |
| 98N-0453 | Agency Emergency Processing Under OMB Review | Notice | 36241 | 070298f.pdf |
| Request for Nominations for Nonvoting Representatives of Consumer and Industry Interests on Public Advisory Panels or Committees | Notice | 36242 | 070298g.pdf | |
| Request for Nominations for Voting Members on Public Advisory Panels or Committees | Notice | 36244 | 070298h.pdf | |
| 92F-0443 | Dow Corning Corp.; Filing of Food Additive Petition; Amendment | Notice | 36246 | 070298i.pdf |
| 98F-0484 | Eastman Chemical Co. ; Filing of Food Additive Petition | Notice | 36246 | 070298i.pdf |
| 98D-0375 | Draft Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community; Availability | Notice | 36240 | 070298j.pdf |
| Draft Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community | Draft Guidance | 980375gd.pdf | ||
| Appendixes - Qualification Standards for FDA Reviewers Guidance | 98375agd.pdf | |||
| Appendixes - Standards for Ethical Conduct for Employees of the Executive Branch | 98375bgd.pdf | |||
| 95N-0195 | Agreement on Mutual Recognition Between the United States of America and the European Community; Third Party Review Program Under the Sectoral Annex on Medical Devices; Conformity Assessment Bodies | Notice | 36247 | 070298k.pdf |
| Circulatory System Devices Panel of the Medical Devices Advisory Committee;Notice of Meeting | Notice | 36248 | 070298l.pdf | |
| 7/1/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 070198co.pdf | |||
| 97F-0305 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final rule. | 35798 | 070198a.pdf |
| 97D-0525 | Draft Guidance for Industry: “Promoting Medical Products in a Changing Healthcare Environment; 1. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs);” Reopening of Comment Period | Notice; reopening of comment period. | 35937 | 070198b.pdf |
| Draft Guidance for Industry: “Promoting Medical Products in a Changing Healthcare Environment; 1. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs);” | Draft Guidance | 970525gd.pdf | ||
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