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Food Safety

May 23, 2017 | Daily News

President Donald Trump's fiscal 2018 budget proposal would cut FDA's human drug program by $307 million in discretionary budget authority, its medical device program by $182 million, its biologics program by $119 million and its food program by $70 million, resulting in cuts to the agency's workforce and programs even if Congress were to go along with Trump's request to double user fees.

May 22, 2017 | Daily News

President Donald Trump's fiscal 2018 budget proposes cutting FDA's discretionary budget authority by $854 million -- a shortfall that Trump says would be made up if lawmakers agree to his request to double user fees, despite the fact lawmakers on both sides of the aisle have to date rejected that proposal.

May 22, 2017 | Daily News

President Donald Trump's fiscal 2018 budget proposes cutting FDA's discretionary budget authority by $854 million -- a shortfall that Trump says would be made up if lawmakers agree to his request to double user fees, despite the fact lawmakers on both sides of the aisle have to date rejected that proposal.

May 22, 2017 | Daily News

A coalition of groups including the Center for Food Safety sued FDA Monday (May 22) in an attempt to block the voluntary generally recognized as safe (GRAS) notification system created by the agency's August 2016 final rule, which the plaintiffs say violates both the Administrative Procedure Act and the Food, Drug and Cosmetic Act, and is unconstitutional because it forecloses judicial review of GRAS determinations.

May 15, 2017 | Daily News

FDA officially stood up Monday (May 15) an agency-wide plan to move the agency's Office of Regulatory Affairs (ORA) from a geographic-based model to one focused on product types, explained a Monday memo from FDA Commissioner Scott Gottlieb to agency staff, obtained by Inside Health Policy.

May 02, 2017 | Daily News

HHS Secretary Tom Price signaled the administration may push to bring food safety under one roof in a speech to department staff Tuesday laying out a series of actions that will culminate in submission of a draft HHS-wide reform plan, which he dubbed “Reimagine HHS,” to the White House's budget office June 30.

May 01, 2017 | Daily News

Congressional leaders are pushing a tentative bipartisan fiscal 2017 funding agreement that would give FDA $39 million more than its fiscal 2016 enacted level.

May 01, 2017 | Daily News

FDA has delayed by one year implementation of the nationwide menu labeling rule that was set to go into effect May 5 in response to stakeholders' concerns and is asking for advice on how to rewrite the rule.

April 27, 2017 | Daily News

The Trump administration plans to delay implementation of the nationwide menu labeling rule that was set to go into effect May 5, drawing harsh criticism from the top Democrats.

April 25, 2017 | Daily News

FDA Commissioner-nominee Scott Gottlieb said he is open to using new regulatory tools to demonstrate the agency's gold standard of safety and efficacy, and took a muted tone towards President Donald Trump's proposal to reopen FDA's negotiated user fee agreements and the administration's support for Right to Try legislation in his answers to more than 60 written questions from Senate health committee ranking Democrat Patty Murray (WA).

April 20, 2017 | Daily News

Certain FDA regulations on small food manufacturers and farmers impose excessive and impractical requirements in exchange for little public health protections, the American Herbal Products Association wrote in response to President Donald Trump's request for help in identifying regulations that hurt domestic manufacturing.

April 20, 2017 | Daily News

FDA this week signed its third international food safety pact -- recognizing Australia's system as comparable to that of the U.S. after having signed similar agreements with Canada and New Zealand -- and now turns its attention to the EU, an agency spokesperson told Inside Health Policy.

April 19, 2017 | Daily News

FDA should delay by three years the compliance date for changes to the Nutrition Facts Panel to align with the U.S. Department of Agriculture's implementation of the Bioengineered Ingredient Disclosure law, allowing companies to change their labels once rather than twice, the Grocery Manufacturers Association wrote in comments to the Department of Commerce.

April 03, 2017 | Daily News

FDA plans to dissolve its regional food and drug director functions and set up six new positions in charge of commodity-based programs as part of a Program Alignment Initiative launched in 2013.

March 28, 2017 | Daily News

The Trump administration is proposing a $40 million cut in FDA appropriations for the remainder of fiscal 2017, driven primarily by reductions in staffing, according to a document obtained by Inside Washington Publishers, which was recently sent to congressional appropriators.

March 14, 2017 | Daily News

Newly confirmed CMS chief Seena Verma and FDA chief-nominee Scott Gottlieb, if confirmed, face immediate orders from the White House to craft plans to reorganize their agencies to improve efficiency, shift functions to the states or local governments, and merge or shut down any functions for which costs aren't justified by public benefits or are redundant with work of other agencies.

March 06, 2017 | Daily News

States can use alternative payment models to bring prescription drug companies to the negotiating table and lower prices of drugs in the Medicaid drug rebate program without changing laws, researchers from Oregon Health & Science University told congressional advisers on Friday (March 3).

February 28, 2017 | Daily News

Congress' investigative arm is calling on the Trump White House to develop a national strategy to coordinate food safety oversight, which now spans across 16 federal agencies and 30 federal laws, saying in a recent report that a similar request made six years ago to the Obama White House fell flat.

January 30, 2017 | Daily News

President Donald Trump on Monday (Jan. 30) signed an executive order declaring for every new regulation introduced, two must be eliminated in a bid to cut regulations by up to 75 percent, and said any new regulatory burdens must be offset by other deregulatory policies so there are no new regulatory dollars spent during the remainder of fiscal 2017.

January 24, 2017 | Daily News

President Donald Trump put heads of executive departments and agencies on notice that no new rules or guidances should be sent to the Office of the Federal Register (OFR) until a Trump-appointed or designated agency head reviews and approves them, potentially putting controversial FDA draft guidances and notices on such hot-button issues as off-label use, new dietary ingredients, compounding and biosimilars on hold.

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