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February 25, 2019 | Daily News

FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food Policy and Response Frank Yiannas on Monday (Feb. 25) promoted the agency’s food safety goals and programs in a statement that one food safety advocate believes is largely aspirational, as the agency does not have additional resources to help staff its foreign offices and conduct more import inspections.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

February 06, 2019 | Daily News

Despite warnings from the medical device industry that FDA would be slammed by a backlog of medical product applications that piled up during the shutdown, a former FDA advisory told Inside Health Policy the agency’s user fee-funded activities should return to normal operations and workload shortly.

February 04, 2019 | Daily News

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

January 28, 2019 | Daily News

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

January 25, 2019 | Daily News

An FDA advocacy group is stumped as to how FDA will resume operations and receive funding from Congress after President Donald Trump agreed on Friday (Jan. 25) to reopen the federal government for three weeks.

January 24, 2019 | Daily News

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

January 11, 2019 | Daily News

The Congressional Budget Office released a statement Friday (Jan. 11) that their report determining if enacted legislation for the current fiscal year exceeds discretionary budget limits will be delayed until funding for all 12 annual appropriations bills can be accounted for.

January 11, 2019 | Daily News

As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.

January 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

January 11, 2019 | Daily News

As the partial government shutdown nears its third week, FDA is working to restart inspections of domestic high-risk food facilities, though the furloughed workers who perform those inspections will likely go unpaid until the shutdown ends, FDA Commissioner Scott Gottlieb tweeted on Jan. 9

January 09, 2019 | Daily News

FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

January 02, 2019 | Daily News

Nearly two weeks into a government shutdown that has left 41 percent of FDA employees furloughed, an agency expert says the shutdown will disrupt FDA’s long-term planning because it will put off settling the question of how much funding the agency will receive from Congress in 2019.

December 21, 2018 | Daily News

HHS released a contingency staffing plan in anticipation of a possible government shutdown that showed, out of FDA’s 17,397 staff members, 41 percent or 7,053 employees would be furloughed.

December 17, 2018 | Daily News

The head of Alliance for a Stronger FDA warned that FDA food safety inspections would be hit particularly hard should a government shutdown occur on Friday (Dec. 21).

September 13, 2018 | Daily News

The Labor/HHS conference bill agreed to late Thursday (Sept. 13) includes $90.3 billion in discretionary program funds for HHS, or $2.3 billion more than in 2018, invests more in medical research than the president's request, devotes nearly $4 billion to mental health and opioid treatment and omits cuts in the House version that would have blocked CMS' ability to administer the ACA.

August 23, 2018 | Daily News

The Senate passed a fiscal 2019 Labor-HHS spending bill late Thursday (Aug. 23) that didn't include two controversial amendments -- one defunding Planned Parenthood and another allowing the Senate to intervene in the Texas v. HHS case should the court rule to eliminate the mandate for coverage of preexisting conditions.

July 12, 2018 | Daily News

The House Appropriations Committee approved 30-22 a fiscal 2019 HHS funding bill, following a marathon 13-hour markup, that includes a provision blocking any new funding for the Affordable Care Act and prohibiting the use of funding for existing navigator programs.