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Gottlieb's FDA

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket.

September 20, 2018 | Daily News

FDA awarded nearly $3 million worth of grants to five universities to study and recommend improvements in the use of continuous manufacturing of biologics, an emerging manufacturing technique the agency says will reduce manufacturing costs and drive down drug prices.

September 20, 2018 | Daily News

FDA is wholeheartedly embracing continuous manufacturing as a move that will lower drug costs and reduce product shortages, but the Association for Accessible Medicines recently told Inside Health Policy it is concerned the move could have unintended negative consequences for generic drug makers.

September 19, 2018 | Daily News

FDA issued three guidances -- two final and a new draft guide -- intended to help drug manufacturers and repackagers prepare to comply with the upcoming deadline for including product identifiers on product packages or cases, and to help them understand when product packages are exempted from the requirements, known as a grandfathering exemption.

September 19, 2018 | Daily News

FDA is facing pressure to eliminate the requirement that biosimilar sponsors conduct confirmatory powered clinical studies.

September 18, 2018 | Daily News

FDA for the first time has applied its opioid safety protocols to immediate-release (IR) opioids intended for use in an outpatient setting and is requiring that training be made available to nurses and pharmacists -- not just prescribers -- who are involved managing patients with pain, the agency announced Tuesday (Sept. 18).

September 17, 2018 | Daily News

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

September 14, 2018 | Daily News

FDA Commissioner Scott Gottlieb said his agency is discussing with public and private payers the possibility of establishing a subscription-based reimbursement policy that offers an incentive for drug makers to develop new antibiotics while health care providers are pressed to cut down on use of those drugs.

September 14, 2018 | Daily News

The director of public health at Pew Charitable Trusts applauded a broad strategy laid out by FDA Commissioner Scott Gottlieb Friday (Sept. 14) that aims to curb the growth of antibiotic resistant bacteria by facilitating new antibiotic product development using new reimbursement incentives, supporting antimicrobial stewardship, enhancing antimicrobial resistance surveillance and advancing regulatory science.

September 14, 2018 | Daily News

E-cigarette manufacturer JUUL Labs says it will work with FDA to devise a plan for how the company can address the widespread youth use of e-cigarettes, coming in response to FDA Commissioner Scott Gottlieb's announcement that the agency will take enforcement action if JUUL and four other major e-cigarette manufacturers do not respond to the agency's request that they develop plans to reduce youth access and use within 60 days.

September 14, 2018 | Daily News

Three former high-ranking FDA and HHS officials said Stacy Cline Amin, the agency’s newly named chief counsel and former special assistant and senior associate counsel to the president, is more than qualified for her position in terms of education and experience.

September 14, 2018 | Daily News

FDA's Science Board is the latest group to dive into the contentious topic of cell-based food: The board announced Wednesday that it will take up the topic at an Oct. 22 meeting as part of a broader discussion on antibiotic resistance monitoring.

September 13, 2018 | Daily News

FDA issued 54 product-specific drug guidances -- 42 new and 12 revised -- on Thursday (Sept. 13), saying the guidances will encourage generic drug development and increase patient access to generic and complex drugs, including those that currently lack competition.

September 12, 2018 | Daily News

FDA is evaluating the role that e-cigarette flavors play in driving youth use of the products and will factor that into a decision on whether to bump up the compliance deadlines for premarket review, FDA Commissioner Scott Gottlieb announced Wednesday (Sept. 12).

September 12, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Sept. 12) put five major e-cigarette manufacturers on notice that FDA will investigate their sales and marketing practices, including with boots-on-the-ground inspections, to figure out why youth are using and abusing their products.

September 12, 2018 | Daily News

FDA is contemplating moving up the enforcement deadlines for premarket review of e-cigarettes in light of what Commissioner Scott Gottlieb declared is an epidemic of e-cigarette use among teenagers.

September 12, 2018 | Daily News

Two drug industry lawyers, one of whom works for a rare disease-focused nonprofit, have drafted a proposal for FDA to create a rare disease center of excellence similar to the agency’s Oncology Center of Excellence, which was established in 2017.

September 11, 2018 | Daily News

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place.

September 11, 2018 | Daily News

FDA published an internal policy laying out how drug center staff should prioritize drug manufacturing facilities for routine current good manufacturing practice (CGMP) surveillance inspections.

September 11, 2018 | Daily News

Device industry and cybersecurity lawyers plan to soon unveil an in-depth report describing a pathway for medical device manufacturers and the wider health care sector to protect against cybersecurity threats.

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