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Dockets Management
Dockets Entered On September 30, 2005
Table of Contents
Docket # Title
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
2004P-0266 Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005D-0288 International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
2005P-0305 Remove Dietary Supplements that Contain the Drug Pyridoxamine
2005P-0405 Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 291 OYC International Inc Vol #: 214
RPT 292 Loders Croklaan BV Vol #: 214
2004P-0266 Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
PDN 1 HFC-1 to Environmental Working Group Vol #: 1
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
C 105 Bariatric Weight Loss Center Vol #: 9
2005D-0288 International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
C 3 Sanofi-Synthelabo Inc, Aventis Pharmaceuticals (Sanofi-Aventis) Vol #: 1
2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
BKG 1 Background Information Vol #: 1
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
C 21 C Griffin Vol #: 1
C 22 L Squarzini Vol #: 1
C 23 R Van Slambrouck Vol #: 1
C 24 J P Freund Vol #: 1
C 25 J D Cahill Vol #: 1
C 26 M K Hopkins Vol #: 1
C 27 A L Neeter Vol #: 1
C 28 C Revoir Vol #: 1
C 29 M A Morris Vol #: 1
C 30 C Sacher Vol #: 1
C 31 Form Letter Count 16 Vol #: 8
EC 535 Mr. Theodore Rectenwald Vol #: 6
EC 536 American College of Pediatricians Vol #: 6
EC 537 Ms. Sue Turner Vol #: 6
EC 538 n/a Vol #: 6
EC 539 Ms. Pat Dolan Vol #: 6
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
C 29 L B Grossman Vol #: 13
C 30 S L Outly Vol #: 13
2005P-0305 Remove Dietary Supplements that Contain the Drug Pyridoxamine
RC 1 Biostratum Inc Vol #: 1
2005P-0405 Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
ACK 1 HFA-305 to Orthopedic Surgical Manufacturers Association (OSMA) Vol #: 1
CCP 1 Orthopedic Surgical Manufacturers Association (OSMA) Vol #: 1

Page created on October 18, 2005 RSC

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