Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...

More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency. Background In March 2014, a bipartisan group of female senators wrote to FDA , urging it to do more to ensure the equitable participation...

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...

The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly spied on their whistleblowing activities to members of Congress and other oversight agencies. DOJ's motion, filed on 1 October-almost exactly a year after the case was first filed-seeks dismissal based on a "lack of jurisdiction." Bloomberg explains DOJ argues that an...

An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts." The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and v...

A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...

In a statement on 5 June 2012, the German health technology assessment body Institute for Quality and Efficiency in Health Care (IQWiG) said it would reverse its  April 2012 decision not to recommend Eviplera (rilpivirine) for HIV in fixed combination.  The agency said in a statement its change in determination was due to the manufacturer having submitted additional information supporting this dosage form. The company used an alternative so-called vi...

The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies. In a report released for public comment in May 2012, DHHS, working with more than a dozen other federal agencies known as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), said better methods are needed to assess the benefits and...

Australia's Therapeutic Goods Administration (TGA) announced on 1 June the confirmation of Dr. John Skerritt as the new National Manager of the agency, ending a month-long lead-up process. Skerritt replaces Dr. Rohan Hammett, who resigned from the agency in December 2011 , and comes to the agency in the midst of a tremendous reorganization to combine the regulatory authorities of Australia and New Zealand into a single trans-national regulatory authority known as the ...

The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national drug codes (NDCs) for products lacking either a New Drug Application (NDA)or Abbreviated New Drug Application (ANDA) number. The Citizen Petition was filed in December 2011 by Dr. S. Albert Edwards, RAC, who requested FDA phase out the use of NDCs over a three-year period. C...

Australia's Therapeutic Goods Administration (TGA) announced it has appointed Dr. John Skerritt, previously the Deputy Secretary of the Department of Primary Industries in the Victorian government, as the new national manager of TGA. In a statement posted on the agency's website on 2 May, TGA said Skerritt will take control of the agency at the end of May 2012 and said Skerritt is highly qualified to run the agency well. "Skerritt currently leads more than 1200 staff (i...

A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA). "This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medica...