Webcast | Virtual
Event Title
Common Labeling Deficiencies and Tips for Generic Drug Applications
May 7, 2021
Event Title
Common Labeling Deficiencies and Tips for Generic Drug Applications
- Date:
- May 7, 2021
Visit the CDER Small Business and Industry Assistance Webpage
FDA will discuss the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them and other labeling tips. FDA will also provide answers to common labeling questions asked by generic drug applicants.
Topics
- Frequently asked labeling questions from ANDA applicants
- Most common labeling deficiencies and how to avoid them
Audience
- Generic drug industry stakeholders including current and potential applicants who are interested in submitting an application for generic drug development.
FDA Speakers
- Charlene Peterson, PharmD, Label Reviewer
- Younsook Kim, PhD, PharmD, Labeling Reviewer/Special Assistant
- CDR Esther Chuh, PharmD, BCGP, Team Leader
- Marshall Florence, PharmD, Team Leader
Division of Label Review (DLR) | Office of Generic Drugs (OGD) | CDER | FDA
FDA Resources
- FDA's Prescription Drug Labeling Resources
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (draft guidance)
- Public Availability of Labeling Changes in “Changes Being Effected” Supplements (draft guidance)
- Changes to an Approved NDA or ANDA (final guidance)
- Updating ANDA Labeling After the Marketing Application for the RLD Has Been Withdrawn (draft guidance)
- Acceptability of Draft Labeling to Support ANDA Approval (final guidance)
- Referencing Approved Drug Products in ANDA Submissions (draft guidance)
- Good ANDA Submission Practices (draft guidance)
- ANDA Submissions – Content and Format (final guidance)
- 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 (final guidance)
- USP Resources
- USP General Chapter <7> Labeling
- USP General Chapter <659> Packaging and Storage Requirements
- USP General Chapter <112> Nomenclature
- USP General Chapter <1151> Pharmaceutical Dosage Forms