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Gottlieb's FDA

April 04, 2019 | Daily News

FDA will host a public hearing on May 31 to gather information about the health and safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD), to help shape the agency’s regulatory oversight of cannabis, especially in food, the agency announced Tuesday (April 2).

April 04, 2019 | Daily News

Outgoing FDA chief Scott Gottlieb pinpointed complex generic and second-to-market novel drug development as two key areas in which he thinks the agency could have an effect in the drug pricing arena.

April 04, 2019 | Daily News

Nearly two weeks after receiving the green light from the White House budget office, FDA recently proposed a rule clarifying what tobacco manufacturers should include in substantial equivalence (SE) reports.

April 04, 2019 | Daily News

Departing FDA Commissioner Scott Gottlieb plans to return to his role at the American Enterprise Institute as a resident fellow and focus on the hot-button issue of drug pricing, he told the Washington Post.

April 03, 2019 | Daily News

Sen. Elizabeth Warren (D-MA) applauded FDA for funding research on durations of use for antibiotics in food animals.

April 02, 2019 | Daily News

In a white paper released Tuesday (April 2), FDA details an oversight process that outgoing agency commissioner Scott Gottlieb said could allow artificial intelligence-based medical devices to iterate autonomously while still letting FDA provide a reasonable assurance of safety and effectiveness.

April 02, 2019 | Daily News

FDA will host a public hearing May 13 to gather input from stakeholders on what the agency could do to spur the first-ever availability of interchangeable prescription insulin products, coming as lawmakers criticize insulin makers for increasing prices to the point that some patients haven’t been able to afford the life-saving products.

April 01, 2019 | Daily News

The Campaign for Tobacco-Free Kids welcomed an announcement by outgoing FDA Commissioner Scott Gottlieb that the agency will expand its youth e-cigarette prevention campaign beyond social media and high school bathrooms and onto television screens.

March 29, 2019 | Daily News

Outgoing FDA Commissioner Scott Gottlieb suggested Congress consider establishing incentives, including market exclusivity, to help drive development of safer pain medications.

March 28, 2019 | Daily News

American Clinical Laboratory Association (ACLA) president and CEO Julie Khani said she looks forward to starting a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics.

March 28, 2019 | Daily News

FDA is proposing to amend its regulatory framework for mammograms and mammography facilities, which would include for the first time a federal requirement that breast density information be included in communications to patients and health care providers, the agency announced Wednesday (March 27).

March 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb says his agency is looking into less environmentally hazardous methods of medical device sterilization after the Illinois Environmental Protection Agency ordered a large sterilization facility to close in February due to ethylene oxide emissions.

March 26, 2019 | Daily News

FDA has pegged the development of blood pathogen detection technology a “critical priority” to reduce the cost of blood screenings, improve safety of the blood supply and increase the donor pool, outgoing FDA Commissioner Scott Gottlieb and biologics center director Peter Marks say in a Tuesday (March 26) statement.

March 25, 2019 | Daily News

FDA finalized guidance on Friday (March 22) that pinpoints when vape shops engage in modifications to electronic nicotine delivery system (ENDS) products and are subject to the same requirements as tobacco product manufacturers.

March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair are calling for FDA drug center chef Janet Woodcock to step down from her post in order to clear a path for the agency to revamp its regulation of opioids and implement recommendations made in 2017 by the National Academies of Sciences, Engineering, and Medicine.

March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair filed a citizen petition on Thursday (March 21) demanding FDA slap an immediate moratorium on the approval of new opioids until it revamps its regulation and review of new opioids as recommended by the National Academies of Sciences, Engineering, and Medicine in 2017.

March 21, 2019 | Daily News

Stakeholders representing both industry and consumers called for a re-think of FDA’s generally-recognized-as-safe (GRAS) process, where companies can put a new ingredient in food without agency review.

March 20, 2019 | Daily News

FDA will kick off the start of a conversation with stakeholders on reforming dietary supplement law with a public meeting May 16, agency chief Scott Gottlieb tweeted Tuesday (March 19).

March 20, 2019 | Daily News

FDA will kick off the start of a conversation with stakeholders on reforming dietary supplement law with a public meeting May 16, agency chief Scott Gottlieb tweeted Tuesday (March 19).

March 20, 2019 | Daily News

FDA Commissioner Scott Gottlieb said he will testify before Congress in support of FDA’s 2020 budget on April 3, before leaving the agency two days later.

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