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Guidelines for ANSM inspection suites

The ANSM has inspection powers, an important pillar of its mission to monitor the activity of operators contributing to the placing on the national or European market of the health products listed in Article L. 5311-1 of the Code of public health (CSP).

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Deciding When to Submit a 510 (k) for a Software Change to an Existing Device

Deciding When to Submit a 510 (k) for a Software Change to an Existing Device
Guidance for Industry and Food and Drug Administration Staff

Document issued on October 25, 2017.
The draft of this document was issued on August 8, 2016.

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Deciding When to Submit a 510 (k) for a Change to an Existing Device

Document issued on October 25, 2017.
The draft of this document was issued on August 8, 2016.
This document supersedes Deciding When to Submit a 510 (k) for a Change to an Existing Device, dated January 10, 1997.

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Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry

This guidance represents the current thinking of the US Food and Drug Administration (FDA, the Agency, or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance.

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Mutual recognition of inspections at drug manufacturing sites: the ANSM recognized by the US FDA - Press release

The European Union and the United States have concluded an agreement for mutual recognition of inspections carried out on the drug manufacturing sites in their respective territories. This agreement enters its operational phase, the ANSM is among the first health authorities recognized by the US Food and Drug Administration (US FDA).

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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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