Regulatory officials with the US Food and Drug Administration (FDA) have announced the launch of a project they're calling the Therapeutic Area Standards Initiative Project Plan (TASIPP), which aims to develop and implement new standards to aid in the regulatory review of drugs and biologics. Background FDA has long been interested in addressing common bottlenecks in the regulatory review process, believing that such work can generate industry-wide returns in productivi...

The US Food and Drug Administration (FDA) has released two new lists of updated medical devices standards recognized by FDA for the purposes of meeting current good manufacturing practices (CGMPs) and other review requirements. The two lists, Modifications to the List of Recognized Standards, Recognition List Number: 031 and 032 "will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices," FDA e...

US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards. The Office of International Programs The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associat...

The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF). The June 2013 guidance document, ANDAs: Stability Testing of Drug Substances and Products , explains that, "Over the past few years, the Office of Gener...

In December 2012, China's State Food and Drug Administration's (SFDA) National Medical Standardization Technical Committee issued a standard (YY 0505-2012) that is equivalent to the international electromagnetic compatibility testing standard (IEC 60601-1-2), with an effective date of 1 January 2014. To date, the SFDA says it has recognized a number of medical device testing institutions that are qualified to carry out the detection of electromagnetic compatibility of...

The US Food and Drug Administration (FDA) has released a new Federal Register notice indicating the modification of 116 medical device standards recognized by the agency, as well as 38 new device standards now recognized. The oft-updated List of Recognized Standards is generally updated anywhere between one and three times per year, and was last updated in August 2012 and before that in March 2012. It was created under the FDA Modernization Act of 1997, which gav...

The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions. The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's Nationa...

The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...

Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...

The US Food and Drug Administration (FDA) has announced the adoption of a number of new international standards to guide the development and regulatory review of some medical devices. The standards, collected within FDA's List of Recognized Standards , are used by FDA during the premarket review of some products and allow a company or product to claim conformity to the standards to satisfy certain components of the review process. The FDA Amendments Act of 2007...

Under a new piece of bipartisan legislation introduced in the Senate, all federal agencies, including the US Food and Drug Administration (FDA), would be subject to new standards intended establish performance measures and standards. The Government Customer Service Improvement Act of 2012 , sponsored by Sens. Mark Warner (D-VA) and Ron Johnson (R-WI), was introduced in the Senate on 31 July 2012. Under the proposed legislation, the Office of Management and Budget (...