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FDA Guidances - PharmaFacts
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FDA Guidances

FDA Guidances

All Information was adapted from the Food and Drug Administration website as a service to our readers. The most current versions can be found on the FDA Website.

Guidance for Industry and Review Staff: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route

Guidance for Industry and Review Staff: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079245.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

Guidance for Industry: Product Development Under the Animal Rule

Guidance for Industry: Product Development Under the Animal Rule

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

Guidance for Industry: The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy

Guidance for Industry: The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM453225.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.

Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

General Considerations for Animal Studies for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff

Contains Nonbinding Recommendations Draft – Not for Implementation

General Considerations for Animal Studies for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only. Document issued on: October 14, 2015.

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact Judith A. Davis, Office of Device Evaluation, 301- 796-6636, This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

When final, this guidance will supersede “Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices” issued July 29, 2010.

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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Office of Compliance

 

Contains Nonbinding Recommendations Draft - Not for Implementation

Preface

  1. 41 Additional Copies

  2. 42 Additional copies are available from the Internet. You may also send an e-mail request to

  3. 43 This e-mail address is being protected from spambots. You need JavaScript enabled to view it to receive an electronic copy of the guidance. Please use the

  4. 44 document number 1802 to identify the guidance you are requesting.

Click HERE for full Guidance

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