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Subjects (1-12 of 12)
Drug Approval Government Policy United States
1
E-Books/E-Docs
 

Guidance for industry and FDA staff application user fees for combination products.



[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2005] 2005

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:US 2    ---  Available
2
E-Books/E-Docs
 

Guidance for industry and FDA staff how to write a request for designation (RFD).



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2005] 2005

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:R 29    ---  Available
3
E-Books/E-Docs
 

Guidance for industry and FDA staff submission and resolution of formal disputes regarding the timel



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, [2004?] 2004

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:D 63/4    ---  Available
4
E-Books/E-Docs
 

Guidance for industry formal meetings between the FDA and sponsors or applicants.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009] 2009

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:M 47/REV.1    ---  Available
5
E-Books/E-Docs
 

Guidance for industry M4, organization of the CTD.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:OR 3    ---  Available
6
E-Books/E-Docs
 

Guidance for industry M4E, the CTD, efficacy.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:C 73/3    ---  Available
7
E-Books/E-Docs
 

Guidance for industry M4Q, the CTD, quality.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001] 2001

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:C 73/4    ---  Available
8
E-Books/E-Docs
 

Guidance for industry M4S, the CTD, safety.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:C 73/5    ---  Available
9
E-Books/E-Docs
 

Guidance for industry M4S, the CTD, safety appendices.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:C 73/6    ---  Available
10
E-Books/E-Docs
 

Guidance for industry for the submission of chemistry, manufacturing and controls and establishment



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999] 1999

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:C 42/3    ---  Available
11
E-Books/E-Docs
 

Information sheet guidance for institutional review boards and clinical investigators (continuing re



[Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, 1998?] 1998

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:IN 7/7    ---  Available
12
E-Books/E-Docs
 

Reviewer guidance conducting a clinical safety review of a new product application and preparing a r



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005] 2005

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:C 61/5    ---  Available
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