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Gottlieb's FDA

April 04, 2018 | Daily News

FDA Commissioner Scott Gottlieb calls on social media companies and internet service providers (ISPs) to help “crack down” on illegal opioid distribution via the internet, saying the agency wants to collaborate with these firms on responsible approaches to eliminate illegal opioid distribution.

April 04, 2018 | Daily News

FDA hopes to spend $10 million in fiscal 2019 to advance its efforts to help stem opioid misuse and abuse by, among other things, accelerating development of generic abuse-deterrent formulations of opioids (ADFs), the agency states in a budget justification document unveiled Monday (April 2).

April 03, 2018 | Daily News

FDA laid out an updated plan to enhance, communicate and implement a structured benefit-risk framework for drug reviews and approvals.

April 02, 2018 | Daily News

FDA’s top food official expressed frustration that, despite years of work by the agency to promote U.S. food safety, recent data show foodborne illness rates have increased by 10 percent or more for several pathogens.

April 02, 2018 | Daily News

The nation's leading patient advocates sued FDA last Tuesday (March 27) for delaying the date by which tobacco products must comply with the tobacco deeming rule, asking the federal district court in Maryland to vacate the agency's recently published guidance that sets out new compliance deadlines for certain tobacco products.

March 30, 2018 | Daily News

FDA Commissioner Scott Gottlieb argued Wednesday (March 28) that the ability for FDA to pull a company's investigational new drug application is a key way FDA can keep an eye on companies providing experimental drugs pursuant to a federal Right to Try law.

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.