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  • Regulatory NewsRegulatory News

    Senate Committee Advances FDA User Fee Reauthorization Bill

    The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...
  • Regulatory NewsRegulatory News

    More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

    In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics. Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug A...
  • Regulatory NewsRegulatory News

    NIH Task Force Uncovers Major Issues at Suspended Drug Production Unit

    An internal task force at the National Institutes of Health (NIH) has found “widespread and longstanding” problems at its now-suspended pharmaceutical compounding arm, though the deficiencies were not found to have any direct harm on past or current clinical trial participants. The problems were unveiled in a new report from the task force late Thursday, which also includes more information on how NIH is addressing what was first uncovered by a US Food and Drug Administr...