The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
  • Regulatory NewsRegulatory News

    EMA to Continue Parallel Scientific, HTA Advice Following Successful Pilot

    The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs. Due to the success of the pilot, which concluded on Wednesday, EMA says it will continue to offer parallel scientific advice as part of its routine activities. "Our parallel scientific advice fosters...
  • RAPS' LatestRAPS' Latest

    RAPS Seeks Applications for 2016 Fellows

    RAPS is now seeking applications for the 2016 class of RAPS Fellows. Being named a RAPS Fellow is a unique and exceptional achievement within the regulatory profession. Since 2008, the RAPS Fellows program has recognized senior-level regulatory professionals for continued significant contributions to, and leadership in advancing, the global regulatory profession. “Selection as a RAPS Fellow is an honor and an important recognition of those individuals who have ...
  • Regulatory NewsRegulatory News

    Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms

    Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun. And although that love is sure to be a good sign for companies looking to make hefty profits off of the vouchers on the open market (selling for upwards of $350 million), it’s a bad sign for the US Food and Drug Administration (...
  • Regulatory NewsRegulatory News

    Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

    The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program. The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office ...
  • Regulatory NewsRegulatory News

    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
  • Regulatory NewsRegulatory News

    FDA Plans Pilot Project on Clinical Outcome Assessments

    As part of the US Food and Drug Administration’s (FDA) work on patient-focused drug development, the agency is launching a pilot project where it will collate and summarize clinical outcomes on a number of different diseases in one online resource. The clinical outcome assessment (COA) pilot project, announced Wednesday, is intended to be a starting point for companies considering how certain COAs might be used in clinical trials and early drug development. COAs for th...
  • Regulatory NewsRegulatory News

    FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

    The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP." ISO 13485:2003 Submission Pilot In 2010, FDA released ...
  • Regulatory NewsRegulatory News

    EMA Spells Out New Expectations for Adaptive Pathways Applications

    The European Medicines Agency (EMA) has issued a new guidance to help companies applying to its adaptive pathways pilot. Background EMA launched its adaptive pathways pilot in 2014 to speed access to new medicines in areas of "high medical need" by leveraging existing approval pathways to support "early and progressive patient access" to new medicines. Under the pilot, drugs would either be authorized conditionally or in a staggered fashion by narrow indication befor...
  • Regulatory NewsRegulatory News

    MDSAP to Continue Past Pilot Phase in 2016

    Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday. MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to tr...
  • Regulatory NewsRegulatory News

    FDA Raises Fee Rate for Rare Pediatric Disease Priority Reviews for FY2016

    The US Food and Drug Administration (FDA) on Friday announced that it would increase the rare pediatric disease priority review voucher fee rate for FY 2016 by about $200,000. The new rate -- $2,727,000 – is effective on 1 October and will remain in effect for the next year. FDA previously set the fee rates at $2,562,000 for FY 2015 and $2,325,000 for FY 2014. The new rate is based on FDA's estimate that the cost of a standard review for new molecular entity (NME) new dr...
  • Regulatory NewsRegulatory News

    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...