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Gottlieb's FDA

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.

February 25, 2019 | Daily News

In an unusual action taken Friday (Feb. 22), FDA Commissioner Scott Gottlieb and drug center director Janet Woodcock responded broadly to media reports the agency officials believe unfairly call into question the safety and quality of drugs in the United States, especially generic drugs.

February 25, 2019 | Daily News

FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food Policy and Response Frank Yiannas on Monday (Feb. 25) promoted the agency’s food safety goals and programs in a statement that one food safety advocate believes is largely aspirational, as the agency does not have additional resources to help staff its foreign offices and conduct more import inspections.

February 22, 2019 | Daily News

State and federal proposals to ban settlements that delay generic or biosimilar competition likely would not stop the deals AbbVie struck to protect its blockbuster arthritis drug Humira, antitrust lawyers said.

February 22, 2019 | Daily News

FDA took a long-awaited step toward finalizing decades-old monographs for 16 sunscreen ingredients by publishing a wide-ranging proposed rule Thursday (Feb. 21).

February 21, 2019 | Daily News

Regenerative medicine industry experts praised FDA’s release of two final guidances they say provide welcome clarity for cell and gene therapy developers on how their products can qualify for FDA’s expedited review programs, including through the use of novel clinical trial designs and historical controls, as well as by using a common manufacturing protocol to group data from multiple developers and researchers.

February 21, 2019 | Daily News

Officials from FDA’s device center say it is too early to answer many of industry’s questions about the agency’s nascent digital health software precertification program, including those asking what new authority FDA needs to implement the program.

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