Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – Sep. 27, 2018
Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2of19) PDL – Dec.4-5, 2019
Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017
CDER’s Review of the Prescribing Information (11of15) REdI– May 29-30, 2019
FDA’s Labeling Resources for Human Prescription Drugs
Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications
Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Labeling 2017
Understanding FDA's New Intended Use Rule and its Implications
New FDA Menu Labeling Regulations
U.S. FDA Food Labeling Rules - The New Normal
Common Labeling Deficiencies and Tips for Generic Drug Applications
Understanding New Drug Applications (NDAs)
PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Labeling 2017
Labeling for Biological Products (11of19) PDL – Dec.4-5, 2019
Investigational New Drug Workshop
Converting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Labeling 2017
Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12of15) REdI– May 29-30, 2019
Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017
Pediatric Information In Prescribing Information (4of19) PDL – Dec.4-5, 2019
Labeling Finalization: Final Check of Prescribing Information (8of19) PDL – Dec.4-5, 2019
