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Gottlieb's FDA

March 29, 2018 | Daily News

FDA commissioner Scott Gottlieb announced Thursday (March 29) the start of a multi-year Nutrition Innovation Strategy that will include: modernizing the agency's review of product health claims; finalizing FDA's review of the terms healthy and natural; lowering sodium targets for foods; simplifying, where appropriate, nutrition product labeling; and modernizing, and in some cases eliminating, standards of identity.

March 15, 2018 | Daily News

FDA released Thursday (March 15) its much-anticipated advance notice of proposed rulemaking seeking public input on a standard level of nicotine for combustible cigarettes.

March 14, 2018 | Daily News

Several dozen protesters with the disability advocacy group ADAPT have camped outside of the condominium of FDA commissioner Scott Gottlieb since Friday, March 9, demanding the commissioner finalize a regulation, proposed in 2016, that would ban the use of electric shock devices to modify behavior in people with disabilities.

March 13, 2018 | Daily News

FDA Chief Counsel Becky Wood’s recent remarks that FDA is taking a “risk-based approach” toward warning letters, focusing on “significant public health risks, rather than overly technical or insignificant violations,” left one industry attorney pleased, pharma critics frustrated and some policy watchers waiting for more details before predicting how the Trump FDA will deal with off-label promotion.

March 09, 2018 | Daily News

A fundamental change in manufacturing would be needed for the United States to shift from “antiquated” egg-based flu vaccines to newer technologies like cell-based vaccines and recombinant DNA technology, which could pave the way toward a universal vaccine, government experts told lawmakers March 8.

March 09, 2018 | Daily News

FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with postmarket surveillance requirements that would help determine whether health care facilities were able to properly clean and disinfect the companies' devices, the agency announced on Friday (March 9).

March 09, 2018 | Daily News

503B compounder Cantrell Drug Company and FDA have reached a temporary agreement to reinspect the facility after FDA moved to force the company to shut down and the compounder filed a subsequent restraining order against the government, according to a new document filed in the case on Friday (March 9).

March 08, 2018 | Daily News

The 503B compounding pharmacy that FDA and the Department of Justice are asking a federal judge to shut down is fighting back, using its bankruptcy to request a temporary restraining order that would halt any government action for 45 days.

March 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb said Wednesday (March 7) that the agency is working with HHS Secretary Alex Azar on policies that will help bring more biosimilars to the market, including providing regulatory clarity by integrating policy and review functions; offering tools to help sponsors rely on smaller, targeted trials and develop interchangeable products; countering “misperceptions” about biosimilar safety; and harmonizing development with overseas regulatory partners.

March 07, 2018 | Daily News

Three preliminary regulations crafted to help FDA set its approach toward reducing nicotine levels in cigarettes and regulating premium cigars and flavored tobacco cleared the White House Office of Management and Budget Tuesday (March 6).

March 06, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Tuesday (March 6) spotlighted the agency’s efforts to reform the premarket review process for diagnostic tests, and he previewed next steps, which include qualifying third-party reviewers and third-party databases to help with reviews and approvals, reducing regulatory burden on next generation sequencing (NGS) developers, and providing flexibility in clinical analysis and validation.

March 06, 2018 | Daily News

FDA on Tuesday (March 6) granted marketing authorization -- with special controls -- for the first time for a direct-to-consumer (DTC) genetic health report detecting whether users are at risk of developing breast and ovarian cancer.

March 05, 2018 | Daily News

Nearly all published studies evaluating switching between a biologic and a biosimilar show no differences in immunogenicity, safety or efficacy, according to a newly published literature review from top experts at Sandoz, Novartis and Avalere Health.

March 05, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Thursday (March 1) sent letters to Amazon, eBay, Walmart and Jet asking them to voluntarily stop bulk sales of the anti-diarrheal medicine loperamide -- sold under the brand name Imodium A-D.

March 01, 2018 | Daily News

FDA announced Thursday (March 1) that it is working with the Department of Justice to block a registered 503B compounder from “manufacturing, processing, packing, labeling, holding and/or distributing” its product after the company disobeyed FDA's wishes and continued compounding after it had to recall all of its sterile products in July 2017.

March 01, 2018 | Daily News

FDA released a number of guidances Thursday (March 1) providing manufacturers with advice on how to comply with new nutrition labeling requirements related to dietary fiber, added sugar and serving size. Agency Commissioner Scott Gottlieb also announced a new consumer education campaign on nutrition.

February 27, 2018 | Daily News

The Endocrine Society is disappointed that FDA is holding up preliminary results from a new study as further justification of its previous finding that bisphenol A (BPA) is safe for use in food containers and packaging.

February 26, 2018 | Daily News

FDA has launched a pilot program aimed at streamlining the process for requesting orphan drug designation, and has scheduled a public meeting on regulatory issues associated with granting orphan drug designation -- and possibly applying orphan drug incentives -- to tissue-agnostic therapies, the agency announced Monday (Feb. 26).

February 26, 2018 | Daily News

FDA's Office of Prescription Drug Promotion issued a warning to the maker of an abuse-deterrent opioid for allegedly understating the risks of the product, which included printing the limitations of abuse-deterrent technology below the benefits.

February 26, 2018 | Daily News

The Pew Charitable Trusts and the National Association of Boards of Pharmacy in a report released Monday (Feb. 26) praise states for implementing what they believe are best practices in overseeing compounding, but they say more can be done to increase inspection frequency and develop a risk-based inspection framework.

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