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Gottlieb's FDA

November 01, 2018 | Daily News

Four months after authorizing emergency use of dried plasma by the Department of Defense, FDA released draft guidance that aims to spur industry interest in developing dried plasma products for use beyond the battlefield.

October 31, 2018 | Daily News

FDA by mid-November will announce a new comprehensive tobacco and nicotine action plan focused on curbing youth use of and addiction to e-cigarettes, FDA Commissioner Scott Gottlieb said Wednesday (Oct. 31).

October 31, 2018 | Daily News

FDA tobacco center director Mitch Zeller urged the tobacco industry, public health advocates, researchers and policymakers to stop posturing and find some common ground around how to curb youth use of tobacco products.

October 31, 2018 | Daily News

FDA device center chief Jeff Shuren said the agency will release a white paper that details its thinking on machine learning in medical software.

October 31, 2018 | Daily News

FDA approved Novartis’ biosimilar of AbbVie’s blockbuster arthritis drug Humira, which is the world’s bestselling prescription drug, on Tuesday (Oct. 30).

October 25, 2018 | Daily News

In a new report released Thursday (Oct. 25), the White House Council of Economic Advisers touts FDA’s efforts to drive down drug prices by ramping up drug approvals and increasing competition on the marketplace, pointing to both generic and brand drug approvals.

October 25, 2018 | Daily News

FDA on Wednesday (Oct. 24) released a draft guidance aimed at clarifying what systems drug companies must have in place to comply with legal requirements regarding the quarantine and investigation of suspect drugs, as well as the quarantine and disposal of illegitimate drugs.

October 24, 2018 | Daily News

FDA Commissioner Scott Gottlieb expressed concern that, in the bid to bring to market more drugs that address unmet medical needs, the medical product development and regulatory space has lost focus on developing drugs for more common illnesses.

October 24, 2018 | Daily News

President Donald Trump on Wednesday (Oct. 24) signed into law the massive bicameral package of opioid legislation, which the Senate passed Oct. 3.

October 24, 2018 | Daily News

A key House health care committee suggested Tuesday that Congress bolster efforts by federal regulators to get medical device makers and other industries to ferret out cybersecurity vulnerabilities by offering a liability shield for independent cybersecurity researchers when vulnerabilities are reported, and by helping to distinguish between hacking and good-faith efforts to discover security lags.

October 23, 2018 | Daily News

FDA Commissioner Scott Gottlieb and U.S. Department of Agriculture Secretary Sonny Perdue indicated that a framework for the two agencies to jointly regulate cell-based meats could be available as early as next year.

October 23, 2018 | Daily News

FDA will ask two of its advisory committees to weigh in on expanding the availability of naloxone for use in the community during a two-day meeting Dec. 17 and 18, the agency announced Tuesday (Oct. 23).

October 23, 2018 | Daily News

The head of FDA's anesthetic and analgesic advisory committee has joined consumer group Public Citizen in urging FDA to reject approval of AcelRx's DSUVIA, a sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl.

October 22, 2018 | Daily News

Four former FDA commissioners reignited calls for FDA to be further removed from political pressures so as to ensure its decisions as a science-based public health agency are not swayed by political motivations.

October 22, 2018 | Daily News

FDA plans to issue regulations that outline what information should be included in various tobacco product applications, and it will update currently existing guidance on electronic nicotine delivery systems (ENDS) products and e-cigarettes, agency chief Scott Gottlieb says in a press statement Monday (Oct. 22), the same day as FDA's two-day public meeting discussing the tobacco product application review process.

October 19, 2018 | Daily News

FDA is planning to move on a range of deregulatory actions in the medical device space, including implementing the timeframes and procedures for how the agency handles internal review of device-related decisions; no longer publishing lists of certain device approvals and denials; and harmonizing domestic and international quality requirements for devices.

October 19, 2018 | Daily News

FDA wants to help health care providers better understand the different levels of potency across opioid medications, FDA Commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 |

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 | Daily News

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 | Daily News

FDA and the Department of Homeland Security (DHS) have agreed to formally work together to stave off cybersecurity threats facing medical devices.

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