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Results 1 - 50 of 117  for Bainbridge State College

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1
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Book
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Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.

Center for Drug Evaluation and Research (U.S.)

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

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2
Material Type:
Book
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Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.

Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.

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

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3
Material Type:
Book
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Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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4
Material Type:
Book
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Guidance for industry : changes to an approved NDA or ANDA, questions and answers.

Center for Drug Evaluation and Research (U.S.)

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

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5
Material Type:
Book
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Guidance for industry : variations in drug products that may be included in a single ANDA.

Center for Drug Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

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6
Material Type:
Book
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Guidance for industry : changes to an approved NDA or ANDA.

Center for Drug Evaluation and Research (U.S.)

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

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7
Material Type:
Book
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Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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8
Material Type:
Book
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Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances.

Center for Drug Evaluation and Research (U.S.)

Rockville, Md. : Center for Drug Evaluation and Research, Food and Drug Administration, Dept. of Health and Human Services 1987

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9
Material Type:
Book
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Guidelines for submitting samples and analytical data for methods validation.

Center for Drugs and Biologics (U.S.). Office of Drug Research and Review.

Rockville, Md. : Food and Drug Administration, Center for Drugs and Biologics, Office of Drug Research and Review 1987

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10
Material Type:
Book
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Guidance for industry : providing regulatory submissions in electronic format, general considerations.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 1999

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11
Material Type:
Book
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Guidance for industry : classifying resubmissions in response to action letters.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 1998

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12
Material Type:
Book
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Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.

Center for Drug Evaluation and Research (U.S.)

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

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13
Material Type:
Book
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New drug approval : FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate.

United States. Government Accountability Office. United States. Congress. Senate. Committee on Finance.

Washington, D.C. : U.S. Govt. Accountability Office 2009

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14
Material Type:
Book
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Guidance for industry : botanical drug products.

Center for Drug Evaluation and Research (U.S.)

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

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15
Material Type:
Book
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Guidance for industry : NDA's : impurities in drug substances.

Center for Drug Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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16
Material Type:
Book
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Guidance for industry : PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection.

Center for Drug Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

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17
Material Type:
Book
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Guidance for industry : accelerated approval products, submission of promotional materials.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 1999

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18
Material Type:
Book
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Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 1999

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19
Material Type:
Book
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User fees and refunds for premarket approval applications.

Center for Devices and Radiological Health (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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20
Material Type:
Book
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Guidance for industry : revising and ANDA labeling following revision of the RLD labeling.

Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

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21
Material Type:
Book
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Guidance for industry : referencing discontinued labeling for listed drugs in abbreviated new drug applications.

Center for Drug Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

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22
Material Type:
Book
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Guidance for industry : 180-day exclusivity when multiple ANDAs are submitted on the same day.

Center for Drug Evaluation and Research (U.S.)

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

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23
Material Type:
Book
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Guidance for industry : alternate source of the active pharmaceutical ingredient in pending ANDAs.

Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

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24
Material Type:
Book
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Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products.

Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.)

Rockville, MD : Center for Drug Evaluation and Research : Center for Veterinary Medicine 1994

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25
Material Type:
Book
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Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval.

Center for Drug Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

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26
Material Type:
Book
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Guidance for industry : formal dispute resolution, appeals above the division level.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 2000

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27
Material Type:
Book
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Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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 1997

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28
Material Type:
Book
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Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information.

Center for Biologics Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.)

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

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29
Material Type:
Book
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Dose-response information to support drug registration.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1994

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30
RU-486 : demonstrating a low standard for women's health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, May 17, 2006.
Material Type:
Book
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RU-486 : demonstrating a low standard for women's health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, May 17, 2006.

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources.

Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. 2007

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31
Material Type:
Book
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Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).

Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2008

Online access

32
RU-486 : demonstrating a low standard for women's health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, May 17, 2006.
Material Type:
Book
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RU-486 : demonstrating a low standard for women's health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, May 17, 2006.

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources.

Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. 2007

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33
Material Type:
Book
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New drug approval : FDA's consideration of evidence from certain clinical trials : report to congressional requesters.

United States. Government Accountability Office.

Washington, D.C. : U.S. Govt. Accountability Office 2010

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34
Material Type:
Book
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Guidance for industry Q3A impurities in new drug substances.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Sliver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research 2008

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35
Material Type:
Book
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Guidance for industry M2, eCTD specification, questions & answers and change requests.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2005

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36
Material Type:
Book
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Guidance for industry and FDA staff : how to write a request for designation (RFD).

United States. Food and Drug Administration. Office of 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

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37
Material Type:
Book
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Guidance for industry : M4, organization of the CTD.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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38
Material Type:
Book
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Guidance for industry : ANDAs, impurities in drug substances.

Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.

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

Online access

39
Material Type:
Book
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Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.

Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.); Center for Biologics Evaluation and Research (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2010

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40
Material Type:
Book
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E 16 genomic biomarkers related to drug response : context, structure, and format of qualification submissions.

Center for Drug Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2009

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41
Material Type:
Book
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Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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42
Material Type:
Book
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Guidance for industry : ANDAs, impurities in drug products.

Center for Drug Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.

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

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43
Material Type:
Book
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Sunscreen Innovation Act : report (to accompany H.R. 4250) (including cost estimate of the Congressional Budget Office).

United States. Congress. House. Committee on Energy and Commerce, author.

Washington, D.C. : U.S. Government Printing Office 2014

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44
Material Type:
Book
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An Act to Expand the Program of Priority Review to Encourage Treatments for Tropical Diseases.

United States, enacting jurisdiction.

Washington, D.C. : U.S. Government Publishing Office 2014

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45
Issues relating to ephedra-containing dietary supplements : hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Commerce, Trade, and Consumer Protection of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, first session, July 23 and 24, 2003.
Material Type:
Book
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Issues relating to ephedra-containing dietary supplements : hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Commerce, Trade, and Consumer Protection of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, first session, July 23 and 24, 2003.

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection.

Washington, D.C. : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O. Congressional Sales Office 2003

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46
Material Type:
Book
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An Act to Amend the Federal Food, Drug, and Cosmetic Act to Provide an Alternative Process for Review of Safety and Effectiveness of Nonprescription Sunscreen Active Ingredients, and for Other Purposes.

United States, enacting jurisdiction.

Washington, D.C. : U.S. Government Printing Office 2014

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47
Material Type:
Book
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Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.

Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.); Center for Biologics Evaluation and Research (U.S.)

Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research 2008

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48
Material Type:
Website
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Drugs@FDA.

Center for Drug Evaluation and Research (U.S.)

Washington D.C. : U.S. Food and Drug Administration, Center for Drug and Evaluation Research 2004

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49
Material Type:
Book
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FDA user fee agreements : strengthening FDA and the medical products industry for the benefit of patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, second session ... March 29, 2012.

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions, author.

Washington : U.S. Government Printing Office 2014

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50
Material Type:
Book
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Improving Regulatory Transparency for New Medical Therapies Act : report (to accompany H.R. 4299) (including cost estimate of the Congressional Budget Office).

United States. Congress. House. Committee on Energy and Commerce, author. United States. Congress. House. Committee on the Judiciary, author.

Washington, D.C. : U.S. Government Printing Office 2014]-

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