The US Food and Drug Administration (FDA) issued a draft guidance on Wednesday that aims to shed light on how it assesses the benefits and risks of new drugs in deciding whether to approve them. The guidance also describes how companies can present benefit and risk information in their applications to increase chances of approval.   The guidance also addresses how sponsors can collect patient experience data to inform their benefit/risk assessments. It was developed ...

More than four years after the 21 st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Tuesday circulated a discussion draft of their proposed Cures 2.0 legislation, setting the stage for negotiations on the long-awaited legislative package.   In addition to proposing new programs and enhancements for the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), the 127-page draft bill ...

The US Food and Drug Administration (FDA) on Monday released revised draft guidance on rare pediatric disease priority review vouchers (PRVs), which are awarded to companies developing certain rare pediatric disease treatments and can then be sold. From 2014 to today, FDA has issued 20 rare pediatric disease PRVs, with one selling for $350 million to AbbVie in 2015 and more recently selling for between $80 million and $130 million. The revisions to FDA’s guidance i...

The work at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on advanced continuous learning for regulatory processes is informing agency-wide efforts. FDA principal deputy commissioner Amy Abernethy touched on how CDRH projects and other initiatives leverage the continuous learning approach during a Wednesday keynote discussion at AcademyHealth’s Health Datapalooza 2019 in Washington, D.C. In an interview with Focus , Ab...

The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...

Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...

Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday published new draft guidance to help stakeholders submit a proposed draft guidance on patient experience data. The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data. “Today’s guidance document is part of our commitment to advance p...

While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...

The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday. Congress first required FDA to implement a least burdensome approach for reviewing 510(k) and premarket application (PMA) submissions in the 1997 Food and Drug Administration Modernization Act (FDAMA) . Since then...

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices. FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act...

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections. The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive ...

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated. One of the draft guidances, the 13-page “ Clinical and Patient Decision Support Software ,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medic...