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GUIDANCE DOCUMENT


Search for FDA Guidance Documents

Search for official FDA guidance documents and other regulatory guidance.

Guidances - FDA

Guidance documents describe FDA's interpretation of or policy on a regulatory issue (21 CFR 10.115(b)). In general, FDA's guidance documents ...

Guidance Documents - DoD Open Government

Guidance documents include memoranda, statements of policy, interpretive rules, staff manuals, circulars, bulletins, advisories, or frequently asked questions.

1-19.000 – Principles for Issuance and Use of Guidance Documents

The Department's guidance documents should be drafted with the recognition that they do not bind the public (except where binding by operation of a grant award ...

Guidance Document Portal - Diversion Control Division

This guidance document clarifies a misconception amongst some practitioners and pharmacists that Drug Enforcement Administration (DEA)-registered pharmacies may ...

Guidance Documents - U.S. Department of Commerce

This page provides a portal to guidance documents issued by the Department or any of its component bureaus.

Guidance documents - USPTO

Guidance documents. A guidance document is an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a ...

Guidance Documents - DHHS

Guidance documents are written agency statements which lack the force of law but provide information or direction of general application to the public to ...

Guidance Search - U.S. Department of Labor

Individual guidance documents are maintained on the various agency websites, and if you know what agency you are looking for, you may also find guidance by ...

MDCG endorsed documents and other guidance

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017…

HHS Guidance Submissions | Guidance Portal - HHS.gov

Why do we have a Guidance Portal? · HHS Good Guidance Rule · Announcements · Search HHS Guidance Documents · Filter Guidance Documents by ...

Guidance documents – Medical devices - Canada.ca

Health Canada guidance documents to assist in preparing licence applications required when seeking an authorization to sell a medical device ...

Guidance on EU Deforestation Regulation - Green Business

2 OCTOBER 2024. Communication to the Commission - EUDR Guidance Document C_2024_7027_1_EN.pdf. English. (106.89 KB - PDF). Download. Share this ...

Guidance Documents | United States Department of Justice

This guidance document provides information regarding a Drug Enforcement Administration (DEA)-registered practitioner's attestation of the training requirement ...

Significant Guidance Documents - U.S. Department of the Interior

This Bulletin establishes policies and procedures for agencies within the Executive Branch to apply in their development, issuance, and use of significant ...

PFAS — Per- and Polyfluoroalkyl Substances

PFAS Technical and Regulatory Guidance Document. The last full update of this document was September 2023. ⇐ ONLINE DOCUMENT: On this web page, use the ...

Medicare Coverage Guidance Documents - CMS

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that the Secretary make available to the public the ...

Virginia Board of Counseling - Guidance Documents

A guidance document is defined as any document developed by a state agency or staff that provides information or guidance of general applicability to the staff ...

FEMA Guidance Documents

FEMA issues guidance documents to help the public understand how the agency administers its statutory and regulatory authorities.

Software as a Medical Device (SaMD): Definition and Classification

Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, ...