Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Gottlieb's FDA

January 28, 2019 | Daily News

In comments to the agency, two health advocacy organizations urge FDA to partner with other federal agencies to address youth e-cigarette and tobacco product use and addiction.

January 25, 2019 | Daily News

An FDA advocacy group is stumped as to how FDA will resume operations and receive funding from Congress after President Donald Trump agreed on Friday (Jan. 25) to reopen the federal government for three weeks.

January 24, 2019 | Daily News

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

January 24, 2019 | Daily News

FDA issued two draft guidances on Thursday (Jan. 24) that lay out a framework for drug and biologic companies to evaluate their risk management programs, one describing how to develop an assessment plan and the second proposing ways to gauge patient or health care provider knowledge.

January 24, 2019 | Daily News

As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.

January 23, 2019 | Daily News

Despite opposition from industry, FDA is not budging from its plan to require that drug and biologics makers with a product approved through the accelerated approval pathway disclose that information on the product’s Indications and Usage section and include a statement explaining that continued approval may be subject to additional trials to confirm the drug’s clinical benefit.

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?

Pages