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Documents > food and drug administration
FDADocs 5/9/2008 | 0 (0) | 13 | 0 | 0 | English
April 29,2002
Food and Drug Administration Dockets Management Branch, HRA-305 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Subject: Draft Guidance entitled, “Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately Reduce the Risk of Transmission of HIV-l and HCV,” Dated December 2001, Docket N ... more>>
FDADocs 5/5/2008 | 0 (0) | 15 | 0 | 0 | English
January24; 2803 Dockets ManagementBranch (HFA-305) Food and Drug Administration 5630 FishersLane, Room 1061 Rockville, Maryland 20852 Dear Sir or Madam:
CENTER FOR BIOSECURITY, FOOD SAFETY, & PUBLIC HEALTH
6430 Stonehurst Circle LakeWorth, Florida 33467
PREAMBLE/INTRODUCTION The Center for Biosecurity, Food Safety and Public Health (CBFSPH) is a ... more>>
FDADocs 5/9/2008 | 0 (0) | 20 | 0 | 0 | English
January24; 2803 Dockets ManagementBranch (HFA-305) Food and Drug Administration 5630 FishersLane, Room 1061 Rockville, Maryland 20852 Dear Sir or Madam:
CENTER FOR BIOSECURITY, FOOD SAFETY, & PUBLIC HEALTH
6430 Stonehurst Circle LakeWorth, Florida 33467
PREAMBLE/INTRODUCTION The Center for Biosecurity, Food Safety and Public Health (CBFSPH) is a ... more>>
FDADocs 5/9/2008 | 0 (0) | 36 | 0 | 0 | English
FOOD AND DRUG ADMINISTRATION
Center For Biologics Evaluation and Research Memorandum
DATE: October 11, 2000 FROM: Douglas Frazier, Review Committee Chairperson, HFM-345, CBER/DH TO: Sheila Buck, Regulatory Reviewer, HFM-380, CBER/DBA SUBJECT: Biologics License Application STN BL 103788/0 Summary Basis for Approval
The following is a summary basi ... more>>
FDADocs 5/12/2008 | 0 (0) | 22 | 0 | 0 | English
Food and Drug Administration, HHS
Subpart H—Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis
358.701 Scope. 358.703 Definitions. 358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis. 358.720 Permitted combinations of active ingredients. 358.750 Labeling of drug products for the c ... more>>
FDADocs 5/9/2008 | 0 (0) | 24 | 0 | 0 | English
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U.S. FOOD AND DRUG ADMINISTRATION and INFECTIOUS DISEASES SOCIETY OF AMERICA + + + + + ISSUES IN THE DESIGN AND CONDUCT OF CLINICAL TRIALS OF ANTIBACTERIAL DRUGS IN THE TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA + + + + + WORKSHOP + + + + + FRIDAY, JANUARY 18, 2008 + + + + + The workshop convened at 8:00 a.m. in the Kennedy Ballroom of the Crowne ... more>>
FDADocs 5/9/2008 | 0 (0) | 19 | 0 | 0 | English
1 UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION + + + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE + + + + + CIRCULATORY SYSTEM DEVICES PANEL + + + + + MEETING + + + + + TUESDAY, SEPTEMBER 21, 2004 + + + + + The Panel met at 9:00 a.m. in Salons A, B, and C of the Hilton Gaithersburg Washington, D.C./Nort ... more>>
NTIA 6/30/2008 | 0 (0) | 69 | 1 | 0 | English
US-China Joint Commission on Commerce and Trade Medical Device and Pharmaceutical Subgroup Pharmaceutical Task Force Meeting August 30, 2005 Beijing, China Overview The Pharmaceutical Task Force under the U.S. – China Joint Commission on Commerce and Trade (JCCT) Medical Devices and Pharmaceuticals Subgroup met in Beijing, China on August 30, 2005. ... more>>
justia 4/14/2008 | 0 (0) | 17 | 0 | 0 | English
SANDOZ, INC. v. FOOD AND DRUG ADMINISTRATION et al
Doc. 28
Case 1:06-cv-01134-RCL
Document 28
Filed 07/12/2006
Page 1 of 1
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ____________________________________ SANDOZ, INC. , ) ) Plaintiff, ) ) v. ) Civil Action No. 06-1134 (RCL) ) FOOD AND DRUG ) ADMINISTRATION, et. al., ) ) Defendant ... more>>
FDADocs 5/9/2008 | 0 (0) | 18 | 0 | 0 | English
0
Public Health Service ---_____ --.-
Food and Drug Administration Rockville MD 20857
April
30,
2002
Mr. Robert D. Gunderson Phoenix Scientific, Inc. 3915 S. 48th St. Terrace St. Joseph, MO 64503 Dear Mr. Gunderson:
Your petition requesting the Food and Drug Administration to file an ANADA was received by our office on for generic Praziquant ... more>>
justia 4/14/2008 | 0 (0) | 25 | 0 | 0 | English
SANDOZ, INC. v. FOOD AND DRUG ADMINISTRATION et al
Doc. 27
Case 1:06-cv-01134-RCL
Document 27
Filed 07/12/2006
Page 1 of 10
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ____________________________________ SANDOZ, INC. , ) ) Plaintiff, ) ) v. ) Civil Action No. 06-1134 (RCL) ) FOOD AND DRUG ) ADMINISTRATION, et. al., ) ) Defendan ... more>>
justia 4/14/2008 | 0 (0) | 30 | 0 | 0 | English
APOTEX INC. v. FOOD AND DRUG ADMINISTRATION et al
Doc. 25
Case 1:06-cv-00627-JDB
Document 25
Filed 04/19/2006
Page 1 of 37
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
Apotex, Inc., Plaintiff. v. FOOD AND DRUG ADMINISTRATION, et al., Defendants, and TEVA PHARMACEUTICALS USA, INC., Intervenor-Defendant, and RANBAXY PHARMACEUTICAL ... more>>
FDADocs 5/9/2008 | 0 (0) | 21 | 0 | 0 | English
Dockets Management Branch (HFA-305) Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, Maryland 20852
October 10, 2002
Re: Docket 02P-0177: Health Claim: D-taqatose and Noncarioaenicitv
Dear Sir or Madam, Kellogg is submitting this comment to the Food and Drug Administration (FDA) in support of Arla Foods Ingredients’ (Arla Food ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
Food and Drug Administration Live Satellite Teleconference With FDA Commissioner Jane E. Henney, M.D.
Wednesday, April 28, 1999 1-3 p.m. Eastern
As part of the agency's ongoing conversation with stakeholders, Dr. Henney and Dr. Linda A. Suydam, Associate Commissioner for Strategic Management, were available to consumers, health providers, and indus ... more>>
FDADocs 5/12/2008 | 0 (0) | 23 | 0 | 0 | English
Food and Drug Administration, HHS
of benign prostatic hypertrophy cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic hypertrophy is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act ... more>>
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