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Gottlieb's FDA

March 07, 2019 | Daily News

In a win for brand-biologic drug makers, FDA has reversed course on its 2017 decision to require that all biologics follow a nonproprietary naming protocol.

March 07, 2019 | Daily News

A former FDA advisor told Inside Health Policy he thinks FDA Principal Deputy Commissioner Amy Abernethy could fill in as acting FDA commissioner, or possibly even succeed FDA Commissioner Scott Gottlieb when the current commissioner leaves the agency in a month.

March 07, 2019 | Daily News

Medical device industry experts say FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.

March 07, 2019 | Daily News

As a drug industry law firm touts a federal appeals court decision rejecting the Federal Trade Commission’s suit against drug maker Shire ViroPharma for alleged abuse of the citizen petition process as a major win for pharma that could “set the FTC’s litigation authority back decades,” antitrust experts predict the ruling may spur new efforts to stop sham petitioning -- either through legislative routes, or simply by encouraging more and better coordination between FTC and FDA.

March 06, 2019 | Daily News

Shortly after saying he planned to resign from the agency, FDA Commissioner Scott Gottlieb announced a series of steps the agency will take to improve its oversight of the cosmetic industry -- a plan that includes working with Congress to update the 80-year-old regulatory framework and set in place new requirements for the cosmetic industry.

March 06, 2019 | Daily News

FDA Commissioner Scott Gottlieb said he’s “extremely confident” FDA’s policy to ban the sale of flavored e-cigarettes in convenience stores will be released before he leaves his position in a month.

March 06, 2019 | Daily News

Outgoing FDA Commissioner Scott Gottlieb said Wednesday (March 6) that Medicare should inject private negotiation into Medicare Part B, which is in line with HHS’ original plan to design Part B like the retail drug benefit Part D, but he did not mention the current plan to reference foreign drug prices in Part B.

March 06, 2019 | Daily News

FDA Commissioner Scott Gottlieb, who made headlines Tuesday (March 5) with his unexpected resignation announcement, said on Wednesday (March 6) that he would absolutely come back to work in the administration but only after spending some time with his family.

March 05, 2019 | Daily News

FDA Commissioner Scott Gottlieb’s unexpected resignation leaves myriad agency policy and regulatory plans, many of which Gottlieb identified as key priorities, hanging in the balance.

March 05, 2019 | Daily News

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.

March 05, 2019 | Daily News

FDA Commissioner Scott Gottlieb announced Tuesday (March 5) he will leave the agency within the next month and touted his agency’s many accomplishments during his 23 months as chief in a resignation letter to HHS Secretary Alex Azar, but he didn’t say why he was resigning.

March 05, 2019 | Daily News

The House Energy & Commerce Committee is expected to hold a hearing next week on FDA bills aimed at curbing the rise of drug prices, according to lobbyists for drug makers and patients, and the committee also might hold a hearing at the end of the month on pharmacy benefit managers.

March 04, 2019 | Daily News

The Federal Trade Commission settled with the last outstanding defendant stemming from a 2013 Supreme Court case that allowed antitrust scrutiny of settlements in which brand drug makers provide something of value to delay generic competition, averting a federal district court trial that was set to begin Monday (March 4) involving AbbVie.

March 04, 2019 | Daily News

FDA on Monday (March 4) sent a letter to Walgreens corporate management requesting a meeting to discuss corporate-wide issues that might be contributing to its stores’ track record of illegally selling tobacco products to kids.

February 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb told lawmakers that his agency will undertake the first update of its drug efficacy trial standards in 20 years under a multi-pronged plan aimed at making the investigational new drug process more efficient, lowering development costs and possibly making prescription drugs more affordable.

February 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Feb. 27) told House appropriators he would support increasing the federal minimum age for purchasing tobacco to 21, as doing so could help FDA with the immediate problem of addressing youth use of e-cigarettes.

February 28, 2019 | Daily News

The medical device lobby applauded a bill that would let FDA collect new user fees during a lapse in agency funding, allowing the agency to continue reviewing device applications in the event of a future government shutdown.

February 27, 2019 | Daily News

House Energy & Commerce ranking Republican Greg Walden (OR) will speak with FDA Commissioner Scott Gottlieb about marijuana-related issues as part of a regular meeting the congressman has with the agency head, Walden told Inside Health Policy after speaking at an event at the American Enterprise Institute.

February 26, 2019 | Daily News

Three federal health agencies are forming a task force to streamline and coordinate the government’s role in making diagnostic tests available during an emergency.

February 26, 2019 | Daily News

In a draft guidance released Tuesday (Feb. 26), FDA lays out what factors brand and generic drug manufacturers should consider when setting up and using a continuous manufacturing system to produce their products.

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