Kids Library Home

Welcome to the Kids' Library!

Search for books, movies, music, magazines, and more.

     
Available items only
Add Marked to Bag Add All On Page
Authors (1-13 of 13)
United States Food And Drug Administration Office Of Regulatory Affairs
1
E-Book/E-Doc
 

The enforcement story



Rockville, MD : U.S. Food and Drug Administration, Office of Regulatory Affairs 19--

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4039/2:    ---  Available
2
E-Book/E-Doc
 

Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2002] 2002

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:EL 2/3    ---  Available
3
E-Book/E-Doc
 

Guidance for industry 21 CFR part 11, electronic records, electronic signatures, validation.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001] 2001

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/4    ---  Available
4
E-Book/E-Doc
 

Guidance for industry CGMP for phase 1 investigational drugs.



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 : Office of Regulatory Affairs, [2008] 2008

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:IN 8    ---  Available
5
E-Book/E-Doc
 

Guidance for industry computerized systems used in clinical trials.



[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [1999] 1999

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:C 73/2    ---  Available
6
E-Book/E-Doc
 

Guidance for industry formal dispute resolution : scientific and technical issues related to pharmac



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:D 63    ---  Available
7
E-Book/E-Doc
 

Guidance for industry part 11, electronic records : electronic signatures--scope and application.



[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 : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [2003] 2003

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/3    ---  Available
8
E-Book/E-Doc
 

Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:P 49/6    ---  Available
9
E-Book/E-Doc
 

Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Office of the Commissioner : Office of Regulatory Affairs, [2006] 2006

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:P 92/2    ---  Available
10
E-Book/E-Doc
 

Guidance for industry quality systems approach to pharmaceutical CGMP regulations.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:Q 1/2    ---  Available
11
E-Book/E-Doc
 

Guidance for industry standards for securing the drug supply chain : standardized numerical indentif



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER) : Office of Regulatory Affairs, [2009] 2009

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:SE 2    ---  Available
12
E-Book/E-Doc
 

Guidance for industry sterile drug products produced by aseptic processing, current good manufacturi



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:ST 3    ---  Available
13
E-Book/E-Doc
 

Guidance for industry. electronic signatures, scope and application.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003

Rating:

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/5    ---  Available
Add Marked to Bag Add All On Page
Locate in results
 
    
Available items only