Washington, D.C., FDA and Life Sciences partner John Shakow will be the featured speaker on a Feb. 14 webinar titled, “HRSA Final Rule for 340B: New Requirements For Calculating Ceiling Prices & the New Reality of Civil Monetary Penalties.” The Q1 Productions webinar will address:
- Key elements and definitions in the Final Rule, including the potential for retroactive application of penalties
- Methods for calculating 340B ceiling prices, including the codification of penny pricing
- Situational analysis of how new drug pricing will work in practice
- The threat of CMPs, how they will be calculated, and under what circumstances they will be imposed by OIG
- Other important takeaways for manufacturers’ compliance in 340B
More information can be found here.