Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Gottlieb's FDA

April 26, 2018 | Daily News

In a speech at Datapalooza on Thursday (April 26), FDA commissioner Scott Gottlieb announced a slew of new agency initiatives aimed at spurring use of data analytics and digital health tools in regulatory decision making and drug development.

April 26, 2018 | Daily News

Leading medical device industry groups suggested during a closed-door meeting on Capitol Hill this week that the industry's future depends on Congress overhauling CMS' coverage process to ensure breakthrough devices approved by FDA also are promptly reimbursed as additional data are collected.

April 25, 2018 | Daily News

E-cigarette maker JUUL Labs announced Wednesday (April 25) that it will support federal and state initiatives to raise the minimum age to purchase tobacco products to 21.

April 25, 2018 | Daily News

FDA on Tuesday (April 24) demanded retailers stop selling e-cigarettes to youth and provide information requested by the agency or face regulatory action, following a nationwide blitz that revealed numerous violations related to illegal sales of JUUL Labs’ products.

April 24, 2018 | Daily News

The Senate health committee on Tuesday (April 24) voted 22-1 in favor of reforming FDA's nearly 50-year-old monograph process for reviewing over-the-counter (OTC) drugs via legislation that would authorize a new FDA user fee program for OTC drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug.

April 24, 2018 | Daily News

Amyotrophic lateral sclerosis (ALS), marijuana and sunscreen were the three most frequently searched drug-related terms on FDA’s social media accounts, according to a new report from the agency’s drug center.

April 23, 2018 | Daily News

FDA on Friday (April 20) published the first draft guidance -- of what the agency has promised will be two -- to help advance the development of medication-assisted treatment for opioid use disorder.

April 23, 2018 | Daily News

FDA on Monday (April 23) spotlighted its major drug safety initiatives and priorities for 2017 and previewed how those efforts will carry into 2018.

April 20, 2018 | Daily News

Industry attorneys are skeptical that a new draft FDA guidance expanding the abbreviated 510(k) pathway will lead to a dramatic increase in submissions under the pathway, which has been dogged by slow review times and low industry interest.

April 19, 2018 | Daily News

FDA Commissioner Scott Gottlieb provided the first indications Thursday (April 19) as to what policies are likely to be included in his upcoming plan to boost biosimilar development, namely lowering the bar for demonstrating interchangeability and making it easier for biosimilars to extrapolate across indications -- moves that track with a White House drug pricing report put out earlier this year.

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.

Pages