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  • Regulatory NewsRegulatory News

    Senate Committee Advances OTC Monograph Reform Bill

    The Senate Health, Education, Labor and Pensions Committee on Thursday advanced a bill by voice vote that would reform the way over-the-counter (OTC) drugs are brought to market by creating a user fee system like the ones used for prescription drugs and devices. The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create ...
  • Regulatory NewsRegulatory News

    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
  • Regulatory NewsRegulatory News

    Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs

    Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments. Neonatal Exclusivity Voucher Last month, Sen. Robert Casey (D-PA) introduced a bill, known as Promoting Life-Saving New Therapies for Neonates Act of 201...
  • FDA Releases Long-Awaited Draft Guidance on Clinical Trials

    The US Food and Drug Administration (FDA) has released an extensive new guidance document that one of its top drug regulatory officials says is aimed at "greatly increase[ing] the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective." Writing in a blog posting on the FDA Voice blog on 17 December 2012, FDA's Bob Temple, deputy director for clinical science at the Center for Drug Evaluation and Research (CDER), sa...
  • Proposed Legislation Would Restrict Access to Common Cough Suppressant

    • 17 July 2012
    A new piece of legislation introduced in the US Senate seeks to prevent the abuse of dextromethorphan, a popular cough suppressant found in many over-the-counter (OTC) products and the subject of increasing abuse. The bill, S. 3376 - The Preventing Abuse of Cough Treatments Act of 2012 (PACT Act) , was introduced in the Senate on 11 July by Sen. Bob Casey (D-PA) and is cosponsored by Sens. Richard Blumenthal (D-CT) and Lisa Murkowski (R-AK). In a statement , Casey sai...
  • Senator: Drug Shortage Bill Could Be Bundled With Highway Bill

    A bill submitted for Congressional approval last year by Senator Amy Klobuchar (D-MN) could see approval after Klobuchar indicated she would seek to attach the provision to an important highway bill . The bill, Preserving Access to Life-Saving Medications Act (PALM Act) , was introduced by Sens. Klobuchar and Bob Casey (D-PA) in February 2011, but the legislation has stalled in Congressional committees in the House and Senate. The legislation has attracted 63 cosp...
  • McCain, Casey Introduce Bill to Remove Medical Device Regulations

    Sens. John McCain (R-AZ) and Bob Casey (D-PA) introduced legislation on 3 February that would remove certain regulations that the senators believe is hurting medical device manufacturers and "streamline the pathway" that manufacturers use to bring their innovative products to market. Their bill, the Safe, Efficient, and Transparent Medical Device Approval Act (SET Device Act) (S. 2067) , would require the US Food and Drug Administration (FDA) to modify the de novo a...
  • FDA's Bob Temple Moving from ODE-1 to Other Position

    Bob Temple, the US Food and Drug Administration's (FDA) Director of the Office of Drug Evaluation 1 (ODE-1), is fully assuming his role as Deputy Center Director for Clinical Science and giving up his role as the ODE-1 director, reports BioCentury . Temple was first promoted to the position of Deputy Center Director in November 2009, but has remained in ODE-1. Prior to ODE-1, Temple worked in the Office of Medical Policy, which oversaw the then-named Division of Dru...