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Gottlieb's FDA

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FDA has rewritten a 2015 draft guidance to clarify the tobacco industry can conduct nonclinical lab studies of novel tobacco products without facing agency review or scrutiny.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FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs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FDA released a draft guidance on Wednesday (Feb. 13) that calls for drug industry stakeholders and agency staff to draft a set of pharmaceutical quality consensus standards that potentially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.

February 08, 2019 | Daily News

Device industry lawyers believe FDA’s move toward allowing use of objective performance criteria to evaluate certain new medical devices, rather than relying on predicate devices, could improve the agency’s 510(k) process by creating a more streamlined pathway for well-understood devices.

February 07, 2019 | Daily News

NEW ORLEANS -- Senate Finance Committee Chairman Sen. Chuck Grassley (R-IA) and Sen. Patrick Leahy (D-VT) introduced a bill Tuesday (Feb. 5) that they say would lower drug prices by blocking tactics brand-drug makers use to delay generic drug development by withholding drug samples.

February 07, 2019 | Daily News

Johnson & Johnson announced Thursday (Feb. 7) that it would be the first drug maker to disclose list prices in its television advertisements, the Associated Press first reported.

February 07, 2019 | Daily News

FDA on Thursday (Feb. 7) announced it is barring a Walgreens store in Miami and a Circle K store in Charleston, SC, from selling tobacco products for 30 days due to repeated violations of sales and distribution restrictions, including selling cigars and menthol cigarettes to minors.

February 06, 2019 | Daily News

A group of drug makers and other health care stakeholders wrote to Senate health and Finance committee leaders on Tuesday (Feb. 5) asking them to pass a package of incentives to boost antibiotic development, saying pharmaceutical companies and investors are losing interest in the field due to a lack of return on new product development.

February 06, 2019 | Daily News

Despite warnings from the medical device industry that FDA would be slammed by a backlog of medical product applications that piled up during the shutdown, a former FDA advisory told Inside Health Policy the agency’s user fee-funded activities should return to normal operations and workload shortly.

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