Katie Kramer

Oct 8, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Melissa Bianchi |Joy Sturm |Allison Pugsley |Kathleen Peterson | +6 more

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA) (“Final Guidance”). The Final Guidance largely represents a continuation of CMS’s IPAY 2026 approach.

May 6, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Susan Cook |Kathleen Peterson |Samantha Marshall |Lindsey Johnson | +3 more

On May 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the agency’s oft-stated claim in litigation that its guidance for IPAY 2027 may differ from that for IPAY 2026, the draft guidance largely represents a continuation of CMS’s IPAY 2026 approach.

Mar 22, 2024 | jdsupra.com | Sally Gu |Katie Kramer |Lynn Mehler

For the purpose of this draft guidance, FDA defines a non-interventional study as a study in which patients receive the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.

Mar 15, 2024 | jdsupra.com | Michael Druckman |Katie Kramer |Bryan Walsh

Changes from the draft guidance:In January 2024, FDA published the final guidance “Human Gene Therapy Products Incorporating Human Genome Editing,” finalizing a March 2022 draft guidance of the same name.

Nov 3, 2023 | jdsupra.com | Heidi Forster Gertner |Katie Kramer |Jodi Scott

Since FDA’s issuance of the 2014 draft guidance, FDA has made significant investments in the clinical operations space to increase efficiency, improve diversity and inclusion, and embrace technological advances. These changes include innovations like platforms supporting decentralized research and the ability to target therapies based on genetic variations using machine learning and artificial intelligence.