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Budget

June 07, 2016 | Daily News

A Senate Appropriations subcommittee approved an HHS spending plan Tuesday (June 7) that gives the National Institutes of Health a $2 billion bump, increases funds to fight the opioid epidemic, eliminates funding for the Independent Payment Advisory Board and would fund the Affordable Care Act at 2016 levels.

May 27, 2016 | Daily News

Stakeholders point to the detection of bacteria resistant to a last-resort drug as a reason to accelerate government efforts to combat antimicrobial resistance through increased surveillance and development of new antibiotics.

May 27, 2016 | Daily News

Stakeholders point to the detection of bacteria resistant to a last-resort drug as a reason to accelerate government efforts to combat antimicrobial resistance through increased surveillance and development of new antibiotics. Sen. Michael Bennet (D-CO) urges passage of his bill to accelerate approval of antibiotics for a limited population, and the HHS says the discovery is a reason for lawmakers to move forward with increased funding for efforts to combat antibiotic resistance.

May 17, 2016 | Daily News

The Senate Appropriations agriculture subcommittee cleared a spending bill Tuesday (May 17) that would provide $2.8 billion in discretionary funding for FDA, including a $40.2 million boost for food safety activities.

May 16, 2016 | Daily News

The House is expected to take up a bill this week sponsored by Appropriations Chair Hal Rogers (R-KY) that would provide $622.1 million in funding to combat the Zika virus, which falls far short of President Obama's $1.9 billion emergency supplemental request.

April 22, 2016 | Daily News

House appropriators noted that only 38,370 prescribers of extended-release and long-acting opioids have been trained through FDA's risk evaluation and mitigation strategy since 2012, which is less than half of FDA's prescriber training goal for 2015 and less than 25 percent of the goal for 2016, coming while FDA contemplates extending the REMS program to immediate-release opioids.

April 21, 2016 | Daily News

FDA Commissioner Robert Califf encouraged stakeholders Tuesday (April 19) to push Congress to give more funding for the agency's device center as it works to create a national device evaluation system (NMDES), in remarks at an Alliance for a Stronger FDA meeting.

April 19, 2016 | Daily News

The House Appropriations Committee passed an FDA funding bill that includes report language directing the agency to cease work on its controversial laboratory developed test guidance and to work with Congress on a legislative solution.

April 19, 2016 | Daily News

The House Appropriations Committee passed an FDA spending bill Tuesday (April 19) that hikes funding for food safety oversight, inserts a handful of provisions from the House-passed 21st Century Cures bill, slates $10 million for FDA to combat Zika and Ebola outbreaks, and prevents FDA from limiting sodium in food until bodies outside the agency write dietary reference intake reports.

April 18, 2016 | Daily News

House appropriators say in nonbinding report language that FDA should base any guidance to manufacturers on sodium levels in food on an upcoming revision to Dietary Reference Intake (DRI) values being worked on by the Centers for Disease Control and Prevention and the Institute of Medicine (IOM).

April 18, 2016 | Daily News

FDA rejects congressional appropriator' demand that traditional pharmacies be allowed to compound for office-use purposes, stating in a new draft guidance that generally only outsourcing facilities, which are regulated by the agency, can compound non-patient specific drugs for hospitals, clinicians and health care practitioners.

April 14, 2016 | Daily News

Three provisions of the House-passed 21st Century Cures Act -- Patient-Focused Drug Development, Priority Review for Breakthrough Devices, and Modern Trial Design and Evidence Development -- have made their way into appropriations report language cleared by the House agriculture appropriations subcommittee Wednesday (April 13), a House Energy and Commerce Committee staffer confirmed for Inside Health Policy.

April 14, 2016 | Daily News

Three provisions of the House-passed 21st Century Cures Act -- Patient-Focused Drug Development, Priority Review for Breakthrough Devices, and Modern Trial Design and Evidence Development -- have made their way into appropriations language cleared by the House agriculture appropriations subcommittee Wednesday (April 13), a House Energy and Commerce Committee staffer confirmed for Inside Health Policy.

April 13, 2016 | Daily News

The House agriculture appropriations subcommittee cleared a funding bill Wednesday (April 13) with report language that would delay FDA’s controversial guidance bringing laboratory developed tests under the agency’s medical device paradigm, according to Rep. Rosa DeLauro (D-CT), who said she was upset to see such language in the bill.

April 13, 2016 | Daily News

House appropriators are again trying to force FDA to scrap its controversial generic drug labeling plan in favor of an industry-backed alternative.

March 22, 2016 | Daily News

A bill to cap non-economic damages in medical malpractice suits met the same opposition from states'-rights conservatives at a House Judiciary Committee markup on Tuesday (March 22) as it did in 2011 when the GOP tried to pass the bill.

March 09, 2016 | Daily News

Mandatory funding for FDA and the National Institutes of Health continued to hang over the Senate health committee’s efforts to push forward a counterpart to the House-passed 21st Century Cures package, with lawmakers sparring over the issue at their second markup of health innovation bills.

March 03, 2016 | Daily News

Every Democrat on the Senate health committee has signed on to legislation that would provide an additional $5 billion annually for a handful of programs at FDA and the National Institutes of Health for the next 10 years.

March 02, 2016 | Daily News

The newly minted FDA commissioner faced continued criticism of the agency’s past opioid approval decisions at a hearing on its FY 2017 budget request.

February 25, 2016 | Daily News

Rep. Rosa DeLauro (D-CT) raised concerns Thursday that FDA doesn't have enough money to implement the food safety law, noting at an appropriations hearing that the agency has received less than half of what the Congressional Budget Office said would be needed to implement the Food Safety and Modernization Act (FSMA).

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