Questions and Answers on Quality Related Controlled Correspondence

Field Alert Report Submission: Questions and Answers

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origingenerate

Cooperative Manufacturing Arrangements for Licensed Biologics

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry

Guidance Document-Post-Notice of Compliance (NOC) Changes: Framework Document

Transdermal and Topical Delivery Systems - Product Development and Quality

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software

Q2(R1) Validation of Analytical Procedures: Text and Methodology

Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Best Practices in Developing Proprietary Names for Human Prescription Drug Products

The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controlsgenerate

The "Deemed to be a License" Provision of the BPCI Act: Questions and Answers

Drug Master Files

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry

Development and Submission of Near Infrared Analytical Procedures

ICH Q12: Implementation Considerations for FDA-Regulated Products

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers

Referencing Approved Drug Products in ANDA Submissions

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

ICH Q1F QUALITY GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers