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Gottlieb's FDA

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 03, 2019 | Daily News

As the government shutdown continues into its second week and Congress works to reach a spending deal, it is still unclear what will happen to a legislative package that would reform FDA’s over-the-counter (OTC) drug oversight and reauthorize a number of hazard preparedness programs at HHS.

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 28, 2018 | Daily News

In an attempt to encourage modernization of clinical trials, FDA revised and replaced its 11-year-old guidance outlining its current thinking on oncology endpoints based on context of use, FDA Commissioner Scott Gottlieb announced Wednesday (Dec. 19).

December 26, 2018 | Daily News

FDA has developed a roadmap in the form of draft guidance explaining how stakeholders can develop and submit to the agency a proposed draft guidance relating to patient experience data.

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 21, 2018 | Daily News

With the recent legalization of hemp, a plant in the cannabis family, FDA now goes to work to better define its public health obligations with regard to regulating products containing cannabis or cannabis-derived compounds, such as cannabidiol -- the non-psychoactive substance in cannabis -- FDA Commissioner Scott Gottlieb said in a statement on Thursday (Dec. 20).

December 21, 2018 | Daily News

A bill that would have expanded the government’s definition of “natural cheese” to include additives and artificial ingredients, as well as exclude certain pasteurized process cheeses and plant-based cheeses from the definition, failed in the House on Thursday (Dec. 20) a few hours after Rep. Frank Pallone (D-NJ) called on fellow members to oppose the bill, which he said crossed into FDA's jurisdiction.

December 21, 2018 | Daily News

FDA Commissioner Scott Gottlieb reaffirmed his agency’s pledge to keep a close eye on a female sterility device that has attracted international scrutiny this year for causing serious pain and bleeding in many women implanted with the device.

December 20, 2018 | Daily News

Advancing its goal to support responsible development of safe and effective stem cell treatments, FDA on Thursday (Dec. 20) announced it is sending letters to manufacturers and health care providers who may be offering stem cell therapies to remind them of FDA’s compliance and enforcement policy.

December 20, 2018 | Daily News

FDA Commissioner Scott Gottlieb trumpeted new data showing a decline in sales of antimicrobial products for food-producing animals, and attributed the decline to a 2013 guidance that advised industry on how to eliminate the use of antimicrobials for production purposes, such as growth promotion and feed efficiency.

December 20, 2018 | Daily News

In response to a request from the medical device lobby, FDA is extending by 30 days the comment period for its proposed rule that would waive or alter informed consent regulations for minimal risk clinical investigations, according to an agency notice issued Wednesday (Dec. 19).

December 19, 2018 | Daily News

FDA’s framework for real-world evidence, released Dec. 6, illustrates the agency’s commitment to working with outside groups to expand the use of RWE and real-world data (RWD) in drug approvals and labeling, experts say.

December 19, 2018 | Daily News

Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher-risk devices.

December 18, 2018 | Daily News

FDA announced two actions Tuesday (Dec. 18) aimed at encouraging industry to take advantage of two accelerated review and development pathways for new devices.

December 18, 2018 | Daily News

Surgeon General Jerome Adams issued an advisory on Tuesday (Dec. 18) warning about the dangers of e-cigarettes and urging parents, teachers, health care professionals, and state and local governments to apply known effective strategies to help prevent kids from using e-cigarettes.

December 18, 2018 | Daily News

A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016.

December 17, 2018 | Daily News

Early next year, Amy Abernethy of health care technology service company Flatiron Health will replace FDA’s Rachel Sherman as principal deputy commissioner, FDA Commissioner Scott Gottlieb announced in a memo sent to FDA staff on Monday (Dec. 17).

December 13, 2018 | Daily News

FDA on Thursday (Dec. 13) scrapped a controversial generic drug labeling proposal that would have allowed generic drug makers to update their drug labels with new information independent of labeling changes to the brand reference product.

December 13, 2018 | Daily News

A medical device industry lawyer says a newly unveiled FDA final rule on medical device classification and reclassification improves on the 2014 proposed rule, and it could indicate the agency intends to reclassify more devices as it moves to update its 510(k) process.

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