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Gottlieb's FDA

October 01, 2018 | Daily News

The Drug Enforcement Administration has placed the first FDA-approved cannabidiol (CBD) drug, Epidiolex, under Schedule V of the Controlled Substances Act, and manufacturer GW Pharmaceuticals says the drug should be available in the next six weeks.

September 28, 2018 | Daily News

HHS on Friday (Sep. 28) announced about $2.6 million in prize money for the KidneyX: Redesign Dialysis competition, and Ed Simcox, HHS chief technology officer, said at a briefing that the while the prize competition can encourage innovation, coordination between FDA and CMS to improve patient access will also be part of the KidneyX initiative.

September 28, 2018 | Daily News

The medical device industry may soon have more opportunities to use a faster premarket review program, thanks to proposals included in a draft FDA guidance that would expand the agency’s special 510(k) pathway for reviewing changes in certain devices.

September 27, 2018 | Daily News

FDA Deputy Commissioner Anna Abram urged compounders to be more proactive in keeping their facilities clean, and issued a revised draft guidance on the issue aimed at helping compounders identify unclean conditions in their facilities and implement corrective actions, as well helping state health agencies on their day-to-day oversight.

September 27, 2018 | Daily News

FDA is seeking advice from the public as it weighs the pros and cons of plant-based milk and how the products should be labeled.

September 26, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced an about-face for his agency on Wednesday (Sept. 26) by issuing a draft guidance stating FDA will systematically disclose the names of retailers selling recalled food in certain recall situations.

September 25, 2018 | Daily News

FDA Chief of Staff Lauren Silvis made the case for a legislative proposal the agency sent to Congress last month which would overhaul federal regulation of diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs).

September 24, 2018 | Daily News

FDA issued two guidances on Monday (Sept. 24) -- one final and one draft -- aimed at streamlining the review process for generic, brand and biologics drugs and helping developers submit high-quality applications from the get-go to avoid going through multiple review cycles, the agency announced Monday (Sept. 24).

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.