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Gottlieb's FDA

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.

February 20, 2019 | Daily News

FDA has rewritten a 2015 draft guidance to clarify the tobacco industry can conduct nonclinical lab studies of novel tobacco products without facing agency review or scrutiny.

February 19, 2019 | Daily News

Eli Lilly wants to create “authorized biologics” to avoid rebates on insulin so it can lower the list price of the drug for diabetics who are uninsured or choose to buy insulin products without insurance due to high cost sharing, according to comments filed with FDA and a brand lobbyist familiar with the proposal.

February 15, 2019 | Daily News

FDA on Friday (Feb. 15) finalized a compounding rule that, for the first time, places six bulk drug substances on the list of bulk substances that can be used by compounders not registered as outsourcing facilities -- also known as the 503A bulks list.

February 15, 2019 | Daily News

FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs that have little-to-no competition on the market.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

A bipartisan group of House Energy & Commerce Committee leaders asked to meet with FDA Commissioner Scott Gottlieb to discuss challenges the agency faces in inspecting foreign drug manufacturing facilities.

February 14, 2019 | Daily News

A food safety advocate said she was “crestfallen” that FDA’s final guidance detailing how the food industry and agency staff should issue public warnings and recall notifications does not require companies to disclose the names of retailers involved in the recall.

February 13, 2019 | Daily News

FDA released a draft guidance on Wednesday (Feb. 13) that calls for drug industry stakeholders and agency staff to draft a set of pharmaceutical quality consensus standards that potentially could be recognized by the agency.

February 13, 2019 | Daily News

Two FDA advisory committees on Tuesday (Feb. 12) recommended FDA approve Janssen’s esketamine intranasal spray to treat treatment-resistant depression, which some advisers called a “game changer” for those with TRD.

February 13, 2019 | Daily News

A coalition of organizations focused on health care, public health and safety, drug diversion prevention, and drug abuse prevention and treatment, and a former congresswoman, wrote to FDA Commissioner Scott Gottlieb urging the agency to embrace innovative, at-home systems for disposal of drugs when it implements wide-ranging legislation passed last year as part of congressional efforts to curb the opioid crisis.

February 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Feb. 11) said he hopes to start a “public conversation” about reforming 1994 dietary supplement law to expand the agency’s authority, including in the exclusivity space, coming as FDA also takes steps to beef up its current oversight of the industry.

February 11, 2019 | Daily News

Two FDA advisory panels on Tuesday (Feb. 12) will discuss the safety and efficacy of a novel esketamine drug-device combination intended to treat treatment-resistant depression (TRD), with the proposed treatment marking the first antidepressant product for which a randomized withdrawal trial was used to help show efficacy.

February 08, 2019 | Daily News

FDA on Friday (Feb. 8) updated its public list of brand drugs for which generic drug makers complain they can’t get a hold of the samples needed for generic development.

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