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CREATES Act Becomes Law
January 13, 2020, Covington Alert
On December 20, 2019, the President signed the Further Consolidated Appropriations Act, 2020. Effective on that day, Section 610 of Division N of this Act contains provisions previously introduced in various bills as “the Creating and Restoring Equal Access to Equivalent Samples Act” or “CREATES Act.”
December 19, 2019, Covington Alert
On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a notice of proposed rulemaking on “Importation of Prescription Drugs” (the “NPRM”) and a Draft Guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the ...
October 29, 2018
President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject to filing requirements under subtitle B of Title XI of the Medicare Prescription Drug, Improvement, and ...