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Gottlieb's FDA

January 23, 2019 | Daily News

FDA just took two steps toward realizing a controversial plan that would change parts of the 510(k) process: introducing objective performance criteria and encouraging medical device makers to use younger predicates in their applications.

January 22, 2019 | Daily News

FDA Commissioner Scott Gottlieb said the month-old partial government shutdown “represents one of the most significant operational challenges in FDA’s recent history,” and he warned that more staff will be furloughed as the agency’s drug center runs out of Prescription Drug User Fee Amendment (PDUFA) funding.

January 18, 2019 | Daily News

Food safety advocates say that the month-long partial government shutdown could have long-term negative effects on the morale of FDA’s food inspection staff, as well as FDA’s ability to retain and hire personnel, who might be turned off by the prospect of being furloughed.

January 18, 2019 | Daily News

In an effort to encourage drug companies to develop over-the-counter (OTC) versions of overdose-reversal drug naloxone, FDA has developed a model drug facts label with pictograms that show how to use the drug, which can help consumers better understand how to use naloxone without the supervision of a health care professional, agency chief Scott Gottlieb announced on Thursday (Jan. 17).

January 18, 2019 | Daily News

FDA released final guidance on Thursday (Jan. 17) that the agency says will encourage the development of antimicrobial susceptibility tests (ASTs) to help determine whether a pathogen will likely respond to, or has developed resistance to, certain antimicrobial drugs.

January 17, 2019 | Daily News

Three years after publishing a draft guidance on rare disease drug development, FDA on Wednesday (Jan. 16) released a revised version of the guidance that agency commissioner Scott Gottlieb said will “provide additional advice to innovators on how they can pursue more efficient, effective development programs.”

January 17, 2019 | Daily News

FDA Commissioner Scott Gottlieb tweeted that FDA continues to be concerned that brand biologics companies are misleading the public about the safety and effectiveness of biosimilars, and he warned the agency will take action if it determines a company is purposely creating confusion.

January 17, 2019 | Daily News

A letter Senate Democrats recently sent to FDA Commissioner Scott Gottlieb about the partial government shutdown is likely a political move aimed at highlighting the damage the shutdown is having on the agency while also getting more information that could serve as a foundation for future legislation, a former FDA policy advisor told Inside Health Policy.

January 16, 2019 | Daily News

In a new draft guidance released Wednesday (Jan. 16), FDA provides recommendations to generic drug makers on how to prepare and submit changes to their tentatively approved drug applications so they can receive final lawful approval on the earliest date possible based on patent and exclusivity protections.

January 15, 2019 | Daily News

FDA officials announced a batch of upcoming guidance documents and agency actions they say will help steer a surge of new cell and gene therapy products currently being developed.

January 11, 2019 | Daily News

As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.

January 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

January 11, 2019 | Daily News

As the partial government shutdown nears its third week, FDA is working to restart inspections of domestic high-risk food facilities, though the furloughed workers who perform those inspections will likely go unpaid until the shutdown ends, FDA Commissioner Scott Gottlieb tweeted on Jan. 9

January 10, 2019 | Daily News

Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement pre-cert?

January 09, 2019 | Daily News

Over the next five years, FDA hopes to grow its electronic safety surveillance system, known as Sentinel, into a national data and scientific resource that functions as a multi-purpose center for evidence generation, FDA Commissioner Scott Gottlieb wrote in an FDA Voice blog on Wednesday (Jan. 9).

January 09, 2019 | Daily News

FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month.

January 08, 2019 | Daily News

The House late Tuesday (Jan. 8) passed, for the second time in the past month, a legislative package that would both reauthorize a number of hazard preparedness programs and reform the way FDA regulates over-the-counter (OTC) drugs.

January 08, 2019 | Daily News

FDA is setting up a new Office of Drug Evaluation Science (ODES) that will act as a centralized point of information for various performance metrics and provide more predictable and efficient assessment of safety data, FDA Commissioner Scott Gottlieb announced Tuesday (Jan. 8).

January 08, 2019 | Daily News

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework.

January 07, 2019 | Daily News

The Supreme Court on Monday (Jan. 7) heard oral arguments on a drug labeling case over whether drug maker Merck Sharp & Dohme Corp. should be held liable for injury to consumers even after FDA rejected the company’s proposal to include on its drug label warnings about potential fractures that could be caused by the osteoporosis drug Fosamax.

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