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FDA Compliance and Enforcement Information - Food and Drug

9/15/2014
01:18 | Author: Jeremy Rodriguez

Fda information
FDA Compliance and Enforcement Information - Food and Drug

A summary of information available to the public about the FDA's compliance and enforcement activities.

Page Last Updated: 04/22/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

FDA has authority to take both administrative and judicial actions to protect the public from dangerous and illegal products, to punish persons and companies who violate the law, and to deter violations. Administrative actions are decided upon and taken by the agency in the first instance, although they can be appealed to federal courts. Judicial actions are decided upon and taken by federal courts, at the request of the Department of Justice and FDA.

Warning Letters inform recipients of significant regulatory violations documented during inspections or investigations that may lead to an enforcement action if the violation is not promptly corrected.

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Regulatory Information - Food and Drug Administration

7/14/2014
03:04 | Author: Chloe Allen

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Regulatory Information - Food and Drug Administration

FDASIA gives FDA the authority to collect user fees and fund review of Guidelines for making a Freedom of Information Act request for public.

The Food and Drugs Act of 1906 and other congressional milestones are presented in this section.

Guidances represent FDA's current thinking on a topic. They do not create/confer rights or bind FDA or the public.

FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.

Page Last Updated: 04/23/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Electronic reading rooms contain publicly releasable agency records and other information routinely made available.

Rules and regulations help FDA ensure that regulated products are safe and effective.

Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA.

Protecting and Promoting Your Health.

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Freedom of Information - Food and Drug Administration

5/13/2014
05:06 | Author: Allison King

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Freedom of Information - Food and Drug Administration

Before submitting a FOIA request, please check to see if the information you are looking for is already available on FDA's Web site. You can use our search.

If you wish to visit the FDA FOIA or Dockets Public Reading Room in person, it is located at:

Hours of operation for both sites are 9 a.m. to 4 p.m., Monday through Friday.

Protecting and Promoting Your Health.

Visitors seeking to obtain records via the Public Reading Room are encouraged to call ahead and speak to a DFOI staff member to determine whether the records they are seeking are maintained in the Public Reading Room, available electronically, or would require the submission and processing of a Freedom of Information (FOI) Request.

The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

You can use our search engine to help you find what you're looking for. Before submitting a FOIA request, please check to see if the information you are looking for is already available on FDA's Web site.

Page Last Updated: 10/06/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

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FDA for Consumers - Food and Drug Administration

3/12/2014
07:12 | Author: Chloe Allen

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FDA for Consumers - Food and Drug Administration

3 days ago FDA Helps Tackle Sickle Cell Disease_For Consumer_feature Links to available print publications, information on ordering free copies, and.

Videos, photo slide shows, and audio podcasts.

Timely and easy-to-read articles covering all FDA activities and regulated products.

Page Last Updated: 10/16/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

For seniors, women, patients and patient advocates, parents and caregivers, health educators, students, and kids.

Links to available print publications, information on ordering free copies, and printer-friendly Consumer Update PDFs.

10903 New Hampshire Ave.

Protecting and Promoting Your Health.

Room 5377, Building 32.

Buying medicines online, health fraud, warnings and enforcement, safety alerts, and reporting problems to FDA.

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Information Sheet Guidance for Institutional Review Boards (IRBs)

1/11/2014
09:50 | Author: Jeremy Rodriguez

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Information Sheet Guidance for Institutional Review Boards (IRBs)

FDA Information Sheets: 1998 Update - This document represents the agency's current guidance on protection of human subjects of research.

Page Last Updated: 03/12/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Guidance documents included under the umbrella title of FDA Information Sheets represent the agency's current thinking on protection of human subjects in research. The date following the title of each document represents the most recent update for that subject. As further updates become necessary, reformatting of some documents may therefore be necessary. Many documents were last updated prior to the enactment of good guidance practice requirements. While most will still be included under the umbrella of Information Sheets, some may be accessible separay after update.

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