Child-Resistant Packaging Statements in Drug Product Labeling

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry

Considerations in Demonstrating Interchangeability With a Reference Product

Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection

Interpretation of the "Deemed to be a License" Provision of the Biologics Price Competition and Innovation Act of 2009

Quality Attribute Considerations for Chewable Tablets

Elemental Impurities in Drug Products

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Using the Inactive Ingredient Database Guidance for Industry

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process

Determining Whether to Submit an ANDA or a 505(b)(2) Application

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection

Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

Quality Attribute Considerations for Chewable Tablets Guidance for Industry

Elemental Impurities in Drug Products Guidance for Industry

Labeling for Biosimilar Products

Using the Inactive Ingredient Database

Guideline on the environmental risk assessment of medicinal products for human use

Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles

Data Integrity and Compliance With Drug CGMP Questions and Answers

Postapproval Changes to Drug Substances

Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

Q3C—Tables and List

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials