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Gottlieb's FDA

May 08, 2018 | Daily News

The House Energy & Commerce Committee on Wednesday (May 9) will mark up legislation that would set up a user fee program for and reform FDA's decades-old process for reviewing over-the-counter drugs, the committee announced Monday evening (May 7).

May 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb’s recent remark that the agency's review of tobacco product applications was never the agency’s best way to deal with youth-use of tobacco has reignited debate over the agency's strategy for stemming youth tobacco use.

May 07, 2018 | Daily News

FDA may soon release a guidance on combination product reviews and announce an initiative to offer new incentives for development of devices that manage or treat patient pain, FDA Commissioner Scott Gottlieb said at a medical device conference Thursday (May 3).

May 04, 2018 | Daily News

FDA Commissioner Scott Gottlieb caused confusion when he suggested Thursday (May 3) that the federal government reinterpret the treatment of drug rebates in anti-kickback regulations.

May 03, 2018 | Daily News

FDA on Thursday (May 3) finalized its plan to extend the compliance date for the nutrition facts labeling and serving size labeling rules.

May 03, 2018 | Daily News

FDA's generics drug shop will seek stakeholders' advice on ways the agency could improve its reviews of generic versions of complex pharmaceuticals, as well as other generics in general, at a public workshop May 24.

May 03, 2018 | Daily News

FDA Commissioner Scott Gottlieb, in a wide-ranging speech at the annual Food and Drug Law Institute conference Thursday (May 3), announced a slate of new agency projects, including: making e-cigarettes over-the-counter drug products; reorganizing the FDA drug center; rethinking the regulatory approach toward gene therapy; and developing a framework for regulating genetically modified animals.

May 01, 2018 | Daily News

FDA and the Federal Trade Commission (FTC) on Tuesday (May 1) issued 13 warning letters to e-cigarette sellers and distributors for selling e-cigarette e-liquids that are packaged and labeled similarly to kid-friendly food products, such as juice boxes, lollipops and cookies.

April 30, 2018 | Daily News

An industry attorney leveled a lengthy critique of FDA’s newly created Medical Device Safety Action Plan, calling different steps of the plan “extremely imperialistic,” “expansionist” and outside of FDA’s statutory authority as a regulatory agency.

April 27, 2018 | Daily News

A bipartisan group of House lawmakers hopes to add to the animal drug user fee package moving through Congress a measure that would expand the scope of FDA's animal drug conditional approval pathway so that it applies to large populations of animals.

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.