FDA effectively spends prescription drug user fee collections
After conducting its 2017 review of FDA policies and procedures and financial records related to the FDA’s use of prescription drug user fee collections, the Office of Inspector General (OIG) concluded...
View ArticleOver-the-counter drug monograph reform the topic of subcommittee hearing
Under proposed legislation, “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017,” the over-the-counter (OTC) monograph process would be modernized to streamline rule-making and cut...
View ArticleFDA user fees reauthorized by House vote
In a bipartisan action, the House of Representatives today passed H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, by voice vote. FDARA reauthorizes the FDA’s user fee programs for prescription...
View ArticleEnergy and Commerce committee unanimously approves FDA reauthorization
The House Energy and Commerce Committee voted unanimously—54 to zero—to approve H.R. 2430, the Food and Drug Administration Reauthorization Act of 2017 (FDARA), after a markup on June 7, 2017. The bill...
View ArticleHELP Committee hears ardent support for next round of user fee agreements
Four witnesses expressed their support of the continuation of FDA user fee agreements before the Senate Committee on Health, Education, Labor, and Pensions (HELP) on April 4, 2017. These user fee...
View ArticleCommittee holds optimistic hearing on medical device fees
The Energy and Commerce Subcommittee on Health held a hearing on March 28, 2017, to consider the reauthorization of the FDA Medical Device User Fee Amendments (MDUFA). The MDUFA, set to expire in...
View ArticlePDUFA VI reauthorization would aid 21st Century Cures Act implementation
Since 1992, the Prescription Drug User Fee Act (PDUFA) has authorized the FDA to collect user fees from biopharmaceutical manufacturers to supplement Congressional appropriations. Revenues from these...
View ArticleFDA considers establishing a new ‘Office of Patient Affairs’
The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more...
View ArticleFDA Commissioner Stepping Down After 6 Controversial Years
Dr. Margaret Hamburg, the FDA’s leader for the last six years, announced that she will be stepping down in March 2015. The FDA’s chief scientist, Stephen Ostroff, will become acting commissioner while...
View Article2015 FDA Budget Request Supports 5-Year Strategic Plan
In April 2011, FDA published a five-year strategic plan, entitled “Strategic Priorities 2011 – 2015.” In that plan, FDA set forth five modernization priorities for the agency. The plan also committed...
View ArticleInnovation on Antibacterial Drug Development
The FDA announced that is has formed a task force to support the development of new antibacterial drugs, which the agency has deemed a critical public health care goal. Under the Food and Drug...
View ArticleFiscal Cliff Threatens FDA Reviews
According to a Bloomberg report, a $6.4 billion accord for U.S. drug and medical-device reviews may fall apart three months after taking effect as lawmakers argue over $1.2 trillion government-wide...
View ArticleFDA Industry Letter for Medical Device Establishments Issued
The FDA’s Center for Devices and Radiological Health (CDRH) has issued an industry letter reminding all medical device establishments that for fiscal year (FY) 2013, beginning October 1, 2012, all...
View Article2013 Budget for FDA Approved by Senate Appropriations Committee
The Senate Appropriations Committee has approved a $2.524 billion budget in fiscal year (FY) 2013 for the FDA. The budget will be used to implement the Food Safety and Modernization Act, carry out the...
View ArticleSenate Committee Approves FDA Safety and Innovation Act
On April 25, 2012, the Senate Health, Education, Labor and Pensions (HELP) Committee approved the FDA Safety and Innovation Act to send to the full Senate in May. The legislation passed by the HELP...
View ArticleWeekly Round Up
This week, President Obama signed the “Middle Class Tax Relief and Job Creation Act of 2012″ into effect, extending the payroll tax cut through the end of the year. In other news, The United States...
View ArticleUser Fees Expected to Pay for 98 Percent of FDA Budget Increase Request
The Food and Drug Administration requested a budget of $4.5 billion under the President’s fiscal year (FY) 2013 budget – a 17 percent increase from the enacted budge of FY 2012. In general, while the...
View ArticleEnd of Week Round Up
The biggest news this week has been the recent breaking announcement from the White House concerning the new contraceptive rules in relation to religious employers. Also on Health Wolters Kluwer this...
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