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Gottlieb's FDA

January 09, 2019 | Daily News

Over the next five years, FDA hopes to grow its electronic safety surveillance system, known as Sentinel, into a national data and scientific resource that functions as a multi-purpose center for evidence generation, FDA Commissioner Scott Gottlieb wrote in an FDA Voice blog on Wednesday (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 08, 2019 | Daily News

The House late Tuesday (Jan. 8) passed, for the second time in the past month, a legislative package that would both reauthorize a number of hazard preparedness programs and reform the way FDA regulates over-the-counter (OTC) drugs.

January 08, 2019 | Daily News

FDA is setting up a new Office of Drug Evaluation Science (ODES) that will act as a centralized point of information for various performance metrics and provide more predictable and efficient assessment of safety data, FDA Commissioner Scott Gottlieb announced Tuesday (Jan. 8).

January 08, 2019 | Daily News

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework.

January 07, 2019 | Daily News

The Supreme Court on Monday (Jan. 7) heard oral arguments on a drug labeling case over whether drug maker Merck Sharp & Dohme Corp. should be held liable for injury to consumers even after FDA rejected the company’s proposal to include on its drug label warnings about potential fractures that could be caused by the osteoporosis drug Fosamax.

January 07, 2019 | Daily News

Medical device experts say that crafting new regulatory frameworks for laboratory developed tests (LDTs), digital health apps and medical device cybersecurity are among the top FDA-related issues they will be tracking in 2019.

January 04, 2019 | Daily News

The pharmacy benefit manager (PBM) lobby is proposing FDA prohibit brand drug makers from filing citizen petitions, except for situations involving urgent health issues, in order to curb anticompetitive behavior by the brand-drug industry.

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).

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