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| Dockets Entered
On January 10, 2008
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| Docket #
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| Title
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| 1980N-0314
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| Sodium/Potassium Content of Food Include in Food Labeling
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| 2006D-0228
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| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| 2007D-0463
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| Revised Compliance Policy Guide Sec. 575.100 Pesticide Chemical Residues in Food and Feed Enforcement Criteria (CPG 7141.01)
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| 2007D-0491
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| Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| 2007N-0462
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| Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29); Withdrawal
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| 2007P-0295
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| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0457
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| Mandatory Use of Non-Animal Methods in the Development and Approval of Drugs and Devices
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| 1980N-0314
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| Sodium/Potassium Content of Food Include in Food Labeling
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| ANS 531
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| FDA / HFE88 to Mrs. Newbauer
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| Vol #:
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| 13
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21318
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| LET 21319
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| LET 21320
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| Natural Organics, Inc.
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| Vol #:
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| 193
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| LET 21321
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| LET 21322
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| LET 21323
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| DreamQuest Nutraceuticals
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| Vol #:
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| 183
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| EC 1
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| Mr. David Hernick
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| Vol #:
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| 3
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2006D-0228
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| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| | | | | | | | |
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| EC 22
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| Mr. James Pagano
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| Vol #:
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| 1
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| EC 23
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| OAA,POF,ELOA,EOA,
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| Vol #:
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| 1
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| EC 24
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| Mr. Timothy Hoffpauir
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| Vol #:
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| 1
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| 2007D-0463
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| Revised Compliance Policy Guide Sec. 575.100 Pesticide Chemical Residues in Food and Feed Enforcement Criteria (CPG 7141.01)
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0491
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| Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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| EC 1
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| Dr. Chad Lewis
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| Vol #:
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| 1
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| EC 6
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| None
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| Vol #:
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| 1
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| EC 7
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| Dolle Communications
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| Vol #:
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| 1
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| 2007N-0462
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| Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29); Withdrawal
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0295
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| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| EC 23
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| Ms. Lisa Hartmayer
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| Vol #:
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| 1
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| EC 24
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| UCSF
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| Vol #:
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| 1
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| 2007P-0457
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| Mandatory Use of Non-Animal Methods in the Development and Approval of Drugs and Devices
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| EC 4
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| Ms. Dawn Gurley
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| Vol #:
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| 1
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