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Gottlieb's FDA

April 19, 2018 | Daily News

FDA may be moving closer toward what could be the first approval of a marijuana-based therapy after an advisory panel on Thursday (April 19) unanimously agreed with the agency's preliminary finding in favor of an application for a cannabidiol drug to treat seizures.

April 19, 2018 | Daily News

FDA announced Tuesday (April 17) a five-pronged medical device safety plan that proposes sweeping changes to the way the device center functions, including reorganizing the center to be one large office made up of seven smaller offices that follow individual devices through their lifecycle.

April 17, 2018 | Daily News

FDA's device center may ask Congress for authority to require medical device makers build cybersecurity into their upfront product designs and, once a product is marketed, to disclose any vulnerabilities as they are identified.

April 17, 2018 | Daily News

House appropriators used a Tuesday (March 17) hearing on FDA’s fiscal 2019 budget request to delve into the agency's approach toward tobacco -- leading FDA Commissioner Scott Gottlieb to promise “very vigorous enforcement action” on youth use of vapor products in coming weeks.

April 16, 2018 | Daily News

FDA on Friday (April 13) issued a final guidance on special protocol assessment (SPA) agreements with drug manufacturers that rejects industry's call for a shorter review time, promises more transparency and clarifies that SPAs don't apply to devices.

April 16, 2018 | Daily News

The Campaign for Tobacco-Free Kids is countering arguments that it doesn't have standing to sue FDA for the agency's delay of the tobacco deeming rule compliance dates.

April 16, 2018 | Daily News

FDA on Monday (April 16) issued a revised guidance that pushes back tobacco ingredient listing compliance dates for small-scale manufacturers to Nov. 8, sets a compliance date of May 8 for all other manufacturers and clarifies that the agency will not enforce tobacco ingredient listing submission requirements for certain tobacco product components or parts, including software, digital displays and electrical components.

April 13, 2018 | Daily News

FDA Commissioner Scott Gottlieb again attacked plans for high drug costs, and he honed his explanation for taking on policies under CMS’ purview.

April 13, 2018 | Daily News

FDA took a first step toward encouraging drug companies to enroll pregnant women in clinical trials by putting out a draft guidance that floats scientific and ethical criteria to guide such enrollment, but an industry lawyer suggests formal market incentives and requirements may be needed before drug makers act expeditiously.

April 12, 2018 | Daily News

FDA released two final and one draft guidance Thursday (April 12) aimed at streamlining the process by which in-vitro diagnostic manufacturers can come to market, and the newly unveiled policies may allow certain Next Generation Sequencing tests to be down classified from Class III and be exempted from premarket review.

April 11, 2018 | Daily News

FDA’s controversial pharmaceutical quality metrics program is not dead but is going through a rethink in response to industry complaints, a top FDA official told generic drug stakeholders Wednesday (April 11).

April 09, 2018 | Daily News

FDA announced Monday (April 9) it is restricting the sale and distribution of Essure, a permanent contraceptive device, by limiting the device to prescription use and requiring labeling that specifies the training or experience practitioners must have to prescribe and implant the product.

April 06, 2018 | Daily News

FDA drug center chief Janet Woodcock said she “lives in fear” of providers using outdated treatment methods based on FDA-approved drug labels that, the director admitted, are updated less and less after FDA first approves a drug.

April 05, 2018 | Daily News

FDA is requesting $25 million from congressional appropriators to create a Compounding Center of Excellence, which would be a public-private partnership that performs Good Manufacturing Practice training and market research, the agency explains in a newly released budget justification document.

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.