FDA Guidance and Database for Pharmaceutical Industry

In this article we try to mention the important guidance and database published by USFDA. Which will help you to utilise the FDA resources more efficiently.

Dissolution Methods Database

For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.

Update frequency: Quarterly

Dissolution Testing of Immediate Release Solid Oral Dosage Forms

In this section you will find the recommendations on dissolution testing, specification setting approach, statistical method and bio waiver status for immediate release oral solid dosage form.

Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlation

This guidance provide you the recommendations on method development, dissolution specifications and invivo-invitro correlation (IVIVC) for extended release drug product.

Waiver of InVivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.

This guidance provides recommendation on bio waiver study for immediate release solid dosage form.

SUPAC-IR: Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation

This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of immediate release solid dosage form.

SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation

This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of extended release solid dosage form.

SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation

This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of non sterile semi-solid dosage form.

Inactive Ingredients Search for Approved Drug Products

This database provides the information on inactive ingredients present in USFDA approved drug products. It is helpful for selection of excipients during development.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

This database provides the list of drug products approved by USFDA on the basis of safety and effectiveness. Here you also find the RLD and RS status of  a drug product.

Purple Book: Database of Licensed Biological Products

This database provides the information about all FDA approved biological drug products including biosimilar and interchangeable products, and their reference products.

National Drug Code Directory

This database provides a unique number for pharmaceutical products, which is called NDC number. This number is used for identification purpose.

Abbreviated New Drug Application (ANDA)

This guidance provides recommendation on Laws, Regulations, Policies, and Procedures of ANDA approval. Here you also find the resources for ANDA submission.