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FDA Publications For Sale

The documents below are immediately available. Several Publications are below FDA cost and prices include shipment within the USA. Please make checks payable to Lorentzson Consulting Services.

[Pub-001] Imported drug products and raw material list, alphabetically by product name, NDC number, name of firm and country name.
This list can locate new sources.
CD, $119.00
Hard Copy, $165.00 (887 pages, below FDA cost)

[Pub-003] List of all drug firms registered with FDA in the USA. The list includes: CFN number, lbl code, name and address (by state).
CD, $107.00
Hard Copy, $120.00 (below FDA cost)

[Pub-004] Blueprint to assist in the preparation of Human Drug DMF.
No charge with review.

[Pub-006] FDA Guidance for Industry - for manufacturing, processing or holding of active pharmaceutical ingredients.
Hard Copy, $67.00 (ICHQ7A)

[Pub-009] Outline of FDA GMP requirements for testing labs by FDA personnel.
Hard Copy, $87.00

[Pub-012] FDA Compliance program used by FDA investigators for inspections of drug manufacturing firms (dosage form or A.P.I.).
Hard Copy, $89.00

[Pub-013] Drug Registration and Listing instruction booklet.
Hard Copy (OCT 2003), $107.00

We have other FDA publications that can assist you with FDA GMP Audits, FDA DMF Reviews, FDA HDQTS and so on. Contact us with your concerns. We can help. We'll even assist with the monitoring of Freedom of Information Requests.