FDA Sites - BioPharm International

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FDA Sites
FDA has a massive presence on the Web. The site is so big, it's sometimes difficult to find what you're looking for. The following links should help you narrow down your search for regulatory information.

The FDA home page is a deceptively simple door to a lot of information. Unless otherwise noted, nothing on the site is copyrighted -- neither text nor graphics. The public-domain material may be republished, reprinted, and used freely by anyone without obtaining permission from FDA.

Electronic FOI reading rooms exist because of 1996 amendments to the Freedom of Information Act (FOIA) that mandated publicly accessible "electronic reading rooms," including electronic search and indexing capability.

The FDA dockets management homepage is the official repository for the administrative proceedings and rule-making documents of the FDA.

International Programs The FDA’s Office of International programs includes foreign language documents and information about the activities of the International Conference on Harmonization (ICH).

The FDA Modernization Act of 1997 (FDAMA) has its own home page.

Current Guidances The FDA comprehensive list of current guidance documents published by all the agency centers also provides links to other useful documents from the Office of the Commissioner, including a Small Business Guide to FDA that details procedures, policies, and regulations.

The Center for Biologics Evaluation and Research (CBER) regulates vaccines, blood products, cellular & gene therapy, devises, tissues, and xenotransplantation.

CBER's electronic FOI reading room provides information on approvals, enforcement actions, and product safety. Meeting minutes, speeches, and a handbook for making FOIA requests are also posted.

The Manual of Regulatory Standard Operating Procedures and Policies is essential reading for compliance professionals.

The Center for Drug Evaluation and Research (CDER) regulates therapeutical proteins and monoclonal antibodies (MAbs).

The FDA oncology tools web site offers clinical regulations, contact information, and reference resources such as a list of approved oncology drugs.

Sign up for E-mail Stay informed about changes and additions to the CDER web site by signing up for the daily or weekly email notices.

Questions and Answers on Current Good Manufacturing Practices (cGMPs) for Drugs was begun in 2002 as part of the “CGMPs for the 21st Century Initiative.

The Data Standards Manual is a compilation of standard nomenclature monographs that have been reviewed and approved by the CDER nomenclature standards committee.

Guidance documents represent FDA's current thinking on a particular subject. Find all CDER guidances at this site.

The CDER Handbook was developed to provide a user-friendly resource for information on processes and activities of interest to regulated industry, health professionals, academia, and the public. The handbook has an excellent acronym list. CDER's manual of policies and procedures can be keyword searched.

CDER's regulatory guidance section provides a listing of regulatory and scientific guidances, specific regulatory initiatives, legislation, and compliance activities, including warning letters.

The Office of Regulatory Affairs (ORA) lead office for all FDA field activities, offers inspection and compliance references along with contacts for industry assistance.

FDA and ORA site provides links to documents, lists, policies, programs, and statements relating to compliance references used by FDA personnel.

The Compliance Policy Guide site lists the compliance policy guide manual.

Guide to Inspections. This guide to inspections provides separate resources for biotechnology, biologics, computer issues, devices, drugs, food, cosmetics, and others.

The Guide to Inspection of Quality Systems details the inspectional process used to assess a medical device manufacturer's compliance with the quality system regulations.

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