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Gottlieb's FDA

March 20, 2019 | Daily News

Outgoing FDA Commissioner Scott Gottlieb on Tuesday (March 19) blamed insurers and pharmacy benefit managers for slower biosimilar uptake in the United States than in Europe.

March 19, 2019 | Daily News

FDA is launching a broad effort to revisit implantable device regulation in light of a growing body of data that shows material in some devices could harm certain patients, according to outgoing agency chief Scott Gottlieb and device center head Jeff Shuren.

March 19, 2019 | Daily News

FDA is calling on Congress to pass legislation that would require medical device makers to notify FDA of expected device shortages and would allow temporary importation of critical devices during shortages.

March 19, 2019 | Daily News

Medical device industry lobby groups are asking FDA to make major changes to the draft premarket cybersecurity guidance it released in October, questioning the agency’s proposed two-tier risk system, Cybersecurity Bill of Materials and one-size-fits-all approach.

March 19, 2019 | Daily News

The White House budget office on Tuesday (March 19) finished its review of an FDA proposed rule that lays out the format and content of reports that can be used in premarket submissions to demonstrate substantial equivalence of new tobacco products.

March 18, 2019 | Daily News

Several medical device industry lawyers say FDA guidance that outlines how companies can seek feedback on actions they propose to correct problems found during inspections puts industry in a quandary.

March 15, 2019 | Daily News

FDA on Friday (March 15) finalized a rule that pushes back deadlines for farms to comply with agricultural water standards required in the Food Safety Modernization Act, despite calls from food safety advocates for the agency to implement interim rules to help prevent future foodborne illness outbreaks, such as the 2018 romaine lettuce E. coli outbreaks.

March 13, 2019 | Daily News

FDA Commissioner Scott Gottlieb announced new policy proposals that he expects will effectively ban some flavored e-cigarettes and cigars and restrict others from being used by minors.

March 13, 2019 | Daily News

FDA’s device center announced on Wednesday (March 13) that it will launch its long-planned internal reorganization aimed at addressing the total life cycle of products on March 18 and, should all go as planned, complete the overhaul by Sept. 30, 2019.

March 13, 2019 | Daily News

As speculation of who could be confirmed to permanently replace FDA Commissioner Scott Gottlieb circulates among the media and stakeholders, consumer advocates say they would prefer someone who has fewer ties to industry while one industry consultant hopes the next commissioner will be an outsider who has familiarity with data and technology yet can still work within the guardrails of FDA.

March 12, 2019 | Daily News

National Cancer Institute Director Ned Sharples will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).

March 11, 2019 | Daily News

The White House’s fiscal 2020 skinny budget released Monday (March 11) increases focus on FDA-related proposals that the administration believes could help lower drug costs by increasing competition.

March 11, 2019 | Daily News

Food industry lawyers say that an agreement penned by FDA and the U.S. Department of Agriculture laying out how the two agencies will regulate cell-based meat and poultry products leaves several key questions unanswered, such as how the review process will work, what standards cell-based meats will have to meet for labeling and what the legal justification is for USDA’s role in regulating the non-traditional meat products

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

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.

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