The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process. Background The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to he...

The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program. The fees, which were updated in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , are collected by FDA and used to hire additional review staff and make other improvements at the agency meant to speed up device review times. Under FDASIA , ...

The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...

In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not —have. Background In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that US Food and Drug Administration (FDA), the Office of the National Coordinator (ONC) for Health IT and the Federal Communication Commission all work...

The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD). The report, Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases , was required under Section 510 of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) and based off a...

US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease. Background The meetings are required under the Food and Drug Administration Safety and Innovation Act (FDASIA) , Section X of which called for the US Food and Drug Administration (FDA) to meet with patients in order to better un...

Since the passage of the  Food and Drug Administration Safety and Innovation Act (FDASIA)  in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process. Now the agency is gearing up for its ninth patient-focused drug development meeting, this time focusing on the views of p...

US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says. Background The medical device industry has often lambasted the US Food and Drug Administration's review process as being increasingly  onerous, slow and unpredictable —a view also  shared  by government i...

US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...

On 7 April 2014, a Food and Drug Administration Safety and Innovation Act ( FDASIA )-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress. 1 The workgroup is comprised of representatives from the US Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC). A public workshop was held 13–15 May 2014 to discuss the pr...

An advocacy group focused on accelerating the discovery and approval of new therapies—and in particular therapies for under-served and rare diseases—has launched a new effort aimed at helping to bring patient perspectives into the regulatory process. Background In recent years, regulators and regulatory-minded groups alike have pressed to increase the involvement of patients in the regulatory process. The thinking is that patients are the best stakeholders to ask a...

In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law. Background In 2012, the  Food and Drug...