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Gottlieb's FDA

February 23, 2018 | Daily News

In an updated position statement posted to its website on Feb. 15, the American Cancer Society encourages FDA to regulate all tobacco products, including e-cigarettes “to the full extent of its authority.”

February 16, 2018 | Daily News

FDA published five neurological disease-specific guidance documents as part of its efforts to clearly communicate scientific and regulatory information more efficiently through practical, more concise guidance, FDA Commissioner Scott Gottlieb announced Thursday (Feb. 15).

February 13, 2018 | Daily News

The head of Blue Cross Blue Shield Association's clinical evaluation, innovation and policy shop questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness.

February 13, 2018 | Daily News

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

February 13, 2018 | Daily News

The head of the Blue Cross Blue Shield Association questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness.

February 12, 2018 | Daily News

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

February 12, 2018 | Daily News

The White House is taking on what it views as anticompetitive behavior by some generic drug companies that stave off additional generic entrants by being first to file and then “parking” exclusivity by failing to market their product.

February 12, 2018 | Daily News

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

February 09, 2018 | Daily News

Consumer groups and private laboratories are waiting with bated breath for FDA to get a Food Safety Modernization Act (FSMA)-mandated lab accreditation program, which would certify private laboratories for analyzing food imports, off the ground.

February 08, 2018 | Daily News

FDA, working with the Nuclear Regulatory Commission, approved NorthStar Medical Radioisotopes' RadioGenix System, a “novel manufacturing system” to produce a non-uranium version of radioisotope technetium-99m (Tc-99m), a diagnostic agent used in nuclear imaging studies to detect cancer and coronary artery disease, FDA and Commissioner Scott Gottlieb announced in simultaneous press statements on Thursday (Feb. 8).

February 08, 2018 | Daily News

The Pacific Legal Foundation has filed lawsuits on behalf of nine vape businesses and one nonprofit across three district courts, arguing that FDA's deeming rule violates the First Amendment and is constitutionally invalid because the FDA employee who issued the final rule was not legally authorized to do so.

February 05, 2018 | Daily News

FDA may continue in 2018 to use warning letters as its primary means of regulating cosmetics, according to one law firm whose recent report shows that 2016 and 2017 represented a 10-year high in the number of warnings sent to brands regarding drug claims made for topical skin care products marketed as cosmetics.

February 02, 2018 | Daily News

The nine major medical device and technology companies selected by FDA last fall to be a part of the agency's digital health pre-cert pilot program praised the agency and the program at a two-day public workshop held this week at the National Institutes of Health.

February 02, 2018 | Daily News

The top Republicans on the House Energy & Commerce Committee are requesting FDA create a contingency plan by next month to deal with the possibility of a heparin shortage.

February 01, 2018 | Daily News

Stakeholders are divided over whether there is a need for a national prescription drug monitoring program (PDMP), with some asserting the existing state systems simply need to be improved to enhance interoperability and data sharing and others calling for a national system that would provide real-time data and integrate into clinical workflows.

February 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb told legislators Tuesday (Jan. 30) that FDA will take a risk-based approach to both the yet-to-be-finalized 503B-lite category of compounders and the new model agreement between states and FDA on oversight of compounders that ship products out of state.

February 01, 2018 | Daily News

FDA came under fire from Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions.

January 31, 2018 | Daily News

FDA and the Department of Agriculture finalized an agreement Tuesday (Jan. 30) to formally cooperate on produce safety, biotechnology regulation and oversight of food facilities where they share jurisdiction.

January 30, 2018 | Daily News

FDA on Tuesday (Jan. 30) took what FDA Commissioner Scott Gottlieb painted as “unprecedented and novel action” by calling on marketers of drugs with a potential for abuse and misuse to voluntarily take steps to address public health issues, and specifically asked Imodium A-D makers to change their packaging.

January 30, 2018 | Daily News

FDA recently launched a pilot program under which it will publish the clinical evidence used to support approval of a subset of new drug applications (NDAs).

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