The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)
Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.
Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.
On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.
Read the FDA announcement.
On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).
On Thursday, Dec. 5 the Association of Community Cancer Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.
ACCC's summaries of the CY 2020 OPPS final rule MPFS final rule are available here [login required].
CMS CY2020 OPPS & PFS Final Rules: What You Need to Know
Thursday, December 5, 2019
2:00 – 3:00 PM EST
REGISTER HERE. [Login required]